Devices and methods for ocular surgery

ABSTRACT

A surgical device for cutting a lens within a capsular bag of an eye. Related methods, systems, and devices are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. application Ser.No. 16/221,239, filed Dec. 14, 2018, which claims priority to U.S.Provisional Patent Application Serial Nos. 62/598,857, filed Dec. 14,2017, entitled “Devices and Methods for Ocular Surgery”, and 62/696,769,filed Jul. 11, 2018, entitled “Devices and Methods for Ocular Surgery,”the disclosures of which are hereby incorporated by reference in theirentireties for all purposes.

FIELD

The present technology relates generally to devices and methods forocular surgery with one such procedure being removal of a lens from ahuman eye. More specifically, the technology relates to capturing,fragmenting and extracting of lenticular or other tissue in ophthalmicsurgery.

BACKGROUND

Certain types of conventional ophthalmic surgery require breaking uplenticular tissue and solid intraocular objects, such as the intraocularlens into pieces so that it can be extracted from the eye. For example,extraction of lenses for cataract surgery is one of the most commonoutpatient surgical fields with more than 3 million cases performedannually in the United States alone. During cataract surgery a commonlyused method for lens extraction is phacoemulsification, whichincorporates using ultrasonic energy to break up the lens and thenaspiration to remove the lens fragments through the instrument. Othermethods of lens fragmentation and extraction may include the use ofinstruments such as hooks, knives, or laser to break up the lens intofragments and then extract through an incision in the cornea in an abinterno approach. Intraocular, ab interno fragmentation of thelenticular tissue is extremely important in cataract surgery in order toallow removal of cataracts from ocular incisions that are typically notexceeding 2.8-3.0 mm.

However, existing tools and techniques do not ensure full-thicknessfragmentation of the lens. These techniques approach the lens from theanterior surface of the eye, and therefore the dissection forces exertedby mechanical instruments are limited such that they are ofteninsufficient to accomplish a full-thickness segmentation. Further, dueto the surgical approach through the incision at the edge of the cornea,a mechanical instrument is delivered at an angle substantially parallelto the plane defined by the capsulorhexis. As a result, a conventionalsurgical snare, loop or wire retrieval tool is not in an orientation inwhich that device could be looped around the lens to provide forfragmentation or extraction. Further, even if such a conventional toolcould be looped around the lens, which it cannot, the wire of the snarewould run the risk of applying excessive, damaging force to the capsularbag as it would be moved into position.

Energy-delivery instruments are limited in their ability to cut sectionsof the lens that are physically close to other delicate anatomicalstructures such as the capsular bag. For instance, a laser is generallynot used to cut the posterior edge of the lens because it is in closeproximity to the posterior edge of the capsular bag, leaving a lens thatis not fully fragmented and must be fragmented carefully using secondarytechniques.

For these reasons, phacoemulsification has become the most popularmethod of lens removal. However, phacoemulsification has its owndrawbacks. As fluid and substances are aspirated from the capsular bagand the anterior chamber, other fluids such as saline are inspirated tomaintain a constant volume or pressure. The flow of the fluids in theeye during inspiration and aspiration may create turbulent flow that mayhave a deleterious effect on the tissue within the eye, such as thecorneal endothelium. The ultrasonic energy used in phacoemulsificationcan have its own negative consequences on ocular tissue. Further,phacoemulsification requires expensive and bulky capital equipment,limiting the locations in which phacoemulsification can be perform.

Additionally, certain aspiration and inspiration configurations requirelarge pieces of capital equipment as in the case of phacoemulsificationor may require certain resources such as wall vacuum that may not beavailable in all surgical settings, particularly in underdevelopedareas. A lower cost alternative with the same or better performancewould also be desirable alternative such as one not requiring a costlycontrol console and electronic control system.

SUMMARY

In an aspect, described is a surgical device for cutting a lens within acapsular bag of an eye. The device includes a shaft extending from ahousing along a longitudinal axis of the device. The shaft has a lumenand a distal end. The device includes a cutting element movable throughthe lumen of the shaft. The cutting element includes a first sectioningelement and a second sectioning element. Each of the first and secondsectioning elements has a first end, a second end, and a distal loopformed between the first and second ends. The device includes anactuator operatively coupled to the cutting element. The cutting elementis configured to transition from a first, retracted configurationtowards a second, expanded configuration upon a first activation of theactuator. When in the second, expanded configuration, the distal loop ofeach of the first and second sectioning element defines an enlarged openarea located outside the distal end of the shaft, the enlarged open areahaving a first leg advanced distally relative to the distal end of theshaft and a second leg positioned proximally to the distal end of theshaft.

When the cutting element is in the second, expanded configuration, thedistal loops defining the enlarged open areas of each of the first andsecond sectioning elements can be aligned generally within a planeparallel to one another. A second activation of the actuator or asecond, different actuator can cause the distal loop defining theenlarged open area of one of the first and second sectioning elements tomove angularly relative to the plane transitioning the cutting elementinto a third, splayed configuration. A second activation of the actuatoror a second, different actuator can cause the distal loop defining theenlarged open area of both of the first and second sectioning elementsto move angularly away from one another transitioning the cuttingelement into a third, splayed configuration.

The device can further include an intermediate sectioning elementpositioned between the first and second sectioning elements. Theintermediate sectioning element may also have a first end, a second end,and a distal loop formed between the first and second ends. When thecutting element is in the second, expanded configuration, the distalloop of the intermediate sectioning element can define an enlarged openarea located outside the distal end of the shaft. The enlarged open areaof the intermediate sectioning element can have a first leg advanceddistally relative to the distal end of the shaft and a second legpositioned proximally to the distal end of the shaft. When the cuttingelement is in the second, expanded configuration, the distal loopsdefining the enlarged open areas of each of the first, second, andintermediate sectioning elements can be aligned generally within a planeparallel to one another. A second activation of the actuator or asecond, different actuator can cause the distal loops defining theenlarged open areas of both the first and second sectioning elements tomove angularly away from the intermediate sectioning elementtransitioning the cutting element into a third, splayed configuration.The first and second sectioning elements can move between about 15degrees to about 45 degrees relative to the plane, the plane being asubstantially vertical plane.

The first ends and the second ends of each of the first and secondsectioning elements can be movable relative to the shaft. The first endscan be axially movable along the longitudinal axis of the device. Thesecond ends can be angularly movable relative to the longitudinal axisof the device. The first ends of each of the first and second sectioningelements can be movable relative to the longitudinal axis of the deviceand the second ends of each of the first and second sectioning elementscan be fixed relative to the longitudinal axis of the device. The firstends can be axially movable along the longitudinal axis of the deviceand angularly movable relative to the longitudinal axis of the device.

The actuator can be a slider movable along the longitudinal axis of thehousing. The device can further include a sled positioned within thehousing and coupled to move with the slider relative to the housing. Thesled can include a first loop carrier coupled to the first sectioningelement and a second loop carrier coupled to the second sectioningelement. Movement of the slider a first distance in a distal directionrelative to the housing can translate the sled distally causing thedistal loops of the first and second sectioning elements to define theenlarged open areas and transition the cutting element towards thesecond, expanded configuration. Movement of the slider a second distancein the distal direction beyond the first distance can cause the distalloops defining the enlarged open areas of the first and secondsectioning elements to move angularly away from one anothertransitioning the cutting element into a third, splayed configuration.The first loop carrier can be configured to rotate around a first axisof rotation in a first direction and the second loop carrier can beconfigured to rotate around a second axis of rotation in a seconddirection opposite the first direction. Rotation of the first loopcarrier around the first axis of rotation can cause the distal loop ofthe first sectioning element to splay in the first direction androtation of the second loop carrier around the second axis of rotationcan cause the distal loop of the second sectioning element to splay inthe second opposite direction. Movement of the slider a second distancein the distal direction beyond the first distance can rotate the firstand second loop carriers around their axes of rotation transitioning thecutting element towards a third, splayed configuration. The device canfurther include a wedge positioned within a distal end region of thehousing. Movement of the slider a second distance in the distaldirection beyond the first distance can urge the first and second loopcarriers against the wedge causing the first loop carrier to rotatearound a first axis of rotation in a first direction and causing thesecond loop carrier to rotate around a second axis of rotation in asecond, opposite direction resulting in the distal loops defining theenlarged open areas of the first and second sectioning elements to splayapart. The wedge can be immovable or can be movable in a proximaldirection upon actuation of a second, different actuator. Movement ofthe wedge in a proximal direction can urge the wedge against the firstand second loop carriers causing the first loop carrier to rotate arounda first axis of rotation in a first direction and causing the secondloop carrier to rotate around a second axis of rotation in a second,opposite direction resulting in the distal loops defining the enlargedopen areas of the first and second sectioning elements to splay apart.The wedge can be movable in a proximal direction to cause splay of thefirst and second loop carriers independent of a relative location of thesled along the longitudinal axis of the device.

When the cutting element is in the second, enlarged configuration, thedistal loops defining the enlarged open areas of the first and secondsectioning element can be generally oval in shape and have a maximumwidth of about 4.0 mm to about 20 mm, and a maximum height of about 1.0mm to about 15 mm. The distal loops defining the enlarged open areas ofthe first and second sectioning elements can be configured to splayangularly away from each other transitioning the cutting element intothe third, splayed configuration independent of a size of the enlargedopen areas. The size of the enlarged open areas of the first and secondsectioning elements prior to splay can be selectable. The device canfurther include an adjustor configured to change a relative distancebetween the wedge and the sled. A shorter relative distance can achievea smaller open area of the first and second sectioning elements in thesecond, expanded configuration prior to splay, and a longer relativedistance can achieve a larger open area of the first and secondsectioning elements prior to splay.

In an interrelated implementation, described is a surgical device forcutting a lens within a capsular bag of an eye that includes a shaftextending from a housing along a longitudinal axis of the device. Theshaft has a lumen and a distal end. The device includes a cuttingelement movable through the lumen of the shaft. The cutting elementincludes at least a first sectioning element having a first end, asecond end, and a distal loop formed between the first and second ends.The device includes a slider operatively coupled to the cutting elementand movable along the longitudinal axis of the housing. The deviceincludes a stroke counting mechanism coupled to the slider and containedwithin the housing. The cutting element is configured to transition froma first, retracted configuration towards a second, expandedconfiguration upon distal extension of the slider. When in the second,expanded configuration, the distal loop of the at least a firstsectioning element defines an enlarged open area located outside thedistal end of the shaft, the enlarged open area having a first legadvanced distally relative to the distal end of the shaft and a secondleg positioned proximally to the distal end of the shaft. The strokecounting mechanism is configured to track distal extensions and/orproximal extensions of the slider.

The stroke counting mechanism can be configured to cause a lock-outevent that prevents distal extension of the slider after the lock-outevent. The stroke counting mechanism can include a cylindrical countingbarrel having a plurality of ramp blocks; a hard stop; and a pair ofslider ramps shaped and arranged to engage with the plurality of rampblocks on the counting barrel causing the counting barrel to rotatearound the longitudinal axis of the device. Each distal extension of theslider can turn the cylindrical counting barrel a fraction of a fullrevolution around the longitudinal axis of the device. The cylindricalcounting barrel can be configured to turn up to about 24 fractionsbefore the lock-out event occurs. The lock-out event can prevent distalextension of the slider and allows proximal retraction of the slider.The slider can be configured to extend about 3 to about 30 strokes in adistal direction before the lock-out event occurs and the slider islocked in a rearward position.

The device can include a lock-out warning feature. The lock-out warningfeature can include a lock-out warning window extending through thehousing providing a visible indication of a position of the countingbarrel within the housing relative to the hard stop of the strokecounting mechanism. The counting barrel can be axially movable withinthe housing and have an outer surface having a color that contrasts witha color of the housing. When the counting barrel is positioned near thelock-out warning window, the color of the counting barrel can be visiblethrough the lock-out warning window providing an indication of thedistal extensions of the slider available before the lock-out eventoccurs. The counting barrel can have a series of markings on an outersurface and be fixed relative to the lock-out warning window. The seriesof markings can indicate a number of distal extensions performed by theslider.

The slider can further include a shutter window. When the slider ismoved toward a distal end region of the housing, the shutter window ofthe slider and the lock-out warning window of the housing can alignrevealing the series of markings on the barrel. When the slider is movedproximally away from the distal end region of the housing, the shutterwindow of the slider and the lock-out warning window of the housing maynot align and the series of markings on the barrel are not visible.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects will now be described in detail with referenceto the following drawings. Generally speaking, the figures are not toscale in absolute terms or comparatively, but are intended to beillustrative. Also, relative placement of features and elements may bemodified for the purpose of illustrative clarity.

FIG. 1 is a side schematic view of the ocular anatomy, showing theinsertion of a shaft and sectioning element through an incision in theside of the cornea.

FIG. 2 is a top view of the sectioning element in a deployed position.

FIG. 3 is a perspective view of the capsular bag, with a completedcapsulorhexis, with a sectioning element in a first, retractedconfiguration for insertion.

FIG. 4 is a perspective view of the capsular bag, with a completedcapsulorhexis, with a sectioning element in a second, expandedconfiguration for capture.

FIG. 5 is a perspective view of the capsular bag, with a completedcapsulorhexis, with a sectioning element in a third, fragmentationposition.

FIG. 6 is a perspective view of the lens of FIG. 5, with the sectioningelement not shown for clarity.

FIG. 7 is a perspective view of the lens of FIG. 5, with the sectioningelement and capsular bag not shown for clarity.

FIG. 8 is perspective view of a surgical device including a handle,shaft and multiple sectioning elements.

FIG. 9 is a perspective view of the surgical device of FIG. 8, with thesectioning elements in the first, retracted configuration.

FIG. 10 is a perspective view of the surgical device of FIG. 8, with aleft slider advanced to expand a left sectioning element toward thesecond, expanded configuration.

FIG. 11 is a perspective view of the surgical device of FIG. 8, with aleft slider fully advanced to expand the left sectioning element to thesecond, expanded configuration.

FIG. 12 is a perspective view of the surgical device of FIG. 8, with aright slider advanced to expand a right sectioning element toward thesecond, expanded configuration.

FIG. 13 is a perspective view of the surgical device of FIG. 8, with aright slider fully advanced to expand the right sectioning element tothe second, expanded configuration.

FIG. 14 is a perspective view of FIG. 13, showing the sectioningelements relative to the lens.

FIG. 15 is a detail perspective view of the distal end of the surgicaldevice of FIG. 8.

FIG. 16 is a cutaway perspective view of the handle, with the rightslider in its initial position.

FIG. 17 is a detail perspective view of part of the handle of FIG. 16.

FIG. 18 is a detail perspective view of a different part of the handleof FIG. 16.

FIG. 19 is a detail perspective view of the handle of FIGS. 16-18, withthe right slider partially advanced.

FIG. 20 is a detail perspective view of the handle of FIGS. 16-18, withthe right slider advanced further distally than its position in FIG. 19.

FIG. 21 is a detail perspective view of the handle of FIGS. 16-18, withthe right slider returned toward its original position.

FIG. 22 is a detail perspective view of the handle of FIGS. 16-18, withthe right slider returned to its original position.

FIG. 23 is a side view of another embodiment of two sectioning elementsextending from a shaft to encircle a lens.

FIG. 24A is a perspective view of another implementation of a surgicaldevice including a handle, shaft and multiple sectioning elements priorto deployment.

FIG. 24B is a perspective view of the device of FIG. 24A in a second,expanded configuration.

FIG. 24C is a perspective view of the device of FIG. 24B in a third,splayed configuration.

FIG. 24D is an exploded view of the device of FIG. 24A having threesectioning elements.

FIG. 24E is an exploded view of another implementation of the device ofFIG. 24A having two sectioning elements.

FIG. 25A is a perspective, detail view of the device of FIG. 24Asurrounding a lens.

FIGS. 25B-25C are perspective, detail views of the device of FIG. 25Aafter tensioning and cutting through the lens.

FIG. 26A is an exploded view of the device of FIG. 24A include atwo-phase deployment mechanism.

FIG. 26B is a partial, perspective view of the device of FIG. 24Aillustrating the sled and loop carriers.

FIG. 26C is a partial, end view of the device of FIG. 24A.

FIG. 26D is a partial, perspective view illustrating the loop carrier ofthe device of FIG. 24A prior to splay.

FIG. 26E is a partial, perspective view illustrating the loop carrier ofthe device of FIG. 24A after splay.

FIG. 26F is a top plan view of the wedge of the device of FIG. 24A.

FIGS. 26G-26H illustrates an expansion adjustment mechanism of thedevice of FIG. 24A.

FIGS. 26I-26L are various views of the expansion adjustment mechanism.

FIG. 26M is a partial, perspective view illustrating the loop carrier ofthe device of FIG. 24A prior to splay illustrating an implementation ofa user feedback element.

FIG. 26N is a top plan view of the user feedback element of FIG. 26M.

FIGS. 27A-27C illustrate an implementation of a stroke countingmechanism.

FIGS. 28A-28B illustrate another implementation of a stroke countingmechanism.

FIGS. 29A-29B illustrate another implementation of a stroke countingmechanism.

FIGS. 30A-30E illustrate another implementation of a stroke countingmechanism.

FIG. 31A is perspective view of another implementation of a deviceincluding a stroke counting mechanism.

FIG. 31B is a partial cut-away view of the device of FIG. 31A.

FIG. 31C is an implementation of a counter barrel.

FIG. 31D illustrates slider ramps configured to engage with the counterbarrel of FIG. 31C.

FIG. 31E illustrates the counter barrel of FIG. 31C relative to theslider.

FIG. 31F illustrates an implementation of a lock-out warning for thedevice of FIG. 31A.

FIGS. 32A-32B illustrate another implementation of a stroke countingmechanism.

FIGS. 33A-33C illustrate implementations of sectioning elements formedof a long, narrow band of material.

It should be appreciated that the drawings are for example only and arenot meant to be to scale. It is to be understood that devices describedherein my include features not necessarily depicted in each figure.

DETAILED DESCRIPTION

Described herein are methods and devices for intraocular fragmentationand removal of the lens and other tissues during intraocular surgery.The devices described herein allow for extracting tissue from theanterior chamber without damaging other ocular structures. In variousimplementations, an ocular surgical device is described that usescutting strings, loops, filaments, snares, and the like that aredesigned to engage and fragment the lenticular tissue and aid in itsremoval from the eye in a minimally-invasive, ab interno approach. Inone aspect, provided is a hand-held device that can also be powered(manually) by the user and does not require electronic control. Thedevices described herein are configured for fully adjustable andcustomizable deployment that can occur in a two-step manner (i.e.expansion and rotation or expansion and splay) or a three-step manner(i.e. expansion, rotation, and splay).

Referring now to the figures, FIG. 1 shows the normal anatomy of the eye1 including a cornea 2, capsular bag 6, and a lens 8 within the capsularbag 6. During a cataract procedure, an incision 4 can made in the edgeof the cornea 2 to access the capsular bag 6. The surgeon forms acapsulorhexis 10 on the anterior surface of the capsular bag 6. Thecapsulorhexis 10 can be performed in any suitable manner, such asincising with a scalpel, applying energy with a femtosecond laser orother energy-based cutter, incising under robotic or automated control,or in any other suitable manner. The capsulorhexis 10 can be torn or cutin a diameter of approximately 2.0 mm to 8.0 mm. The capsulorhexis 10may be made smaller in diameter than 2.0 mm, particularly wherefragments of the lens 8 (as described in greater detail below) are smallenough in size to be extracted through a smaller-diameter capsulorhexis10. The capsulorhexis 10 can be made with a separate set of instrumentssuch as micro-forceps, as is commonly done. It is desirable to maintainthe size of the corneal incision to a minimum. For example, cornealincisions that are self-sealing and require no stitches for closure areoptimal for minimally-invasive surgery with the least risk forcomplications. The devices described herein are designed to minimize thesize of incision needed to perform lens fragmentation and removal.

Referring also to FIG. 3, a shaft 12 is then inserted through theincision 4 in the cornea 2. As seen in FIG. 3, the distal end of theshaft 12 is positioned above (i.e., anterior to) the capsulorhexis 10,spaced apart from the capsulorhexis 10 but positioned within thecircumference of the capsulorhexis 10 as viewed from outside the eye 1.As seen in FIG. 1, the shaft 12 is generally parallel to the planedefined by the edges of the capsulorhexis 10 upon its insertion throughthe incision 4 in the cornea 2. In some embodiments, the distal end of asectioning element 16 extends out of an outlet 5 in a lumen 14 at thedistal end of the shaft 12 in a first, retracted configuration. In suchembodiments, the tight radius bend 24 may be positioned outside theshaft 12, already bent at least partially toward the proximal direction.In this way, even in embodiments where the sectioning element 16 isfabricated from superelastic material, the angle through which portionsof the sectioning element 16 are bent during transition from the first,retracted configuration to the second, expanded configuration isreduced. Further, less space is required within the lumen 14 of theshaft 12 to hold part of the sectioning element 16 than to hold all ofit, allowing the shaft 12 to be made smaller in diameter. According tosome embodiments, the shaft 12 is an ovular cross-section tube with arounded tip. The ovular cross-section enhances the ability of the shaft12 to be inserted into the eye 1 through the corneal incision 4.Additionally, in the event that there are multiple sectioning elements,they may be arranged side-by-side more easily in the lumen 14 of anovular cross-section shaft 12. Alternately, the shaft 12 may have acircular cross-section or a cross-section of any other suitable shape.The proximal end of the sectioning element 16 extends through the lumen14 of the shaft 12. Alternately, the entirety of the sectioning element16 is positioned within the lumen 14 of the shaft 12 in the first,retracted configuration. Alternately, more than one sectioning element16 is utilized, where each sectioning element 16 is initially in thefirst, retracted configuration. While a single sectioning element 16 isdescribed with regard to this particular embodiment for clarity, it willbe apparent in light of the further disclosure below that any suitablenumber of sectioning elements 16 may be provided and used in a singlelens removal procedure, and that the devices and methods herein are notlimited to the use of any particular number of sectioning elements 16.Related devices having sectioning elements as described herein aredescribed in U.S. Pat. Nos. 9,775,743 and 9,629,747, which are eachincorporated by reference herein in their entireties.

According to some embodiments, the sectioning element 16 includes afirst end 18 and second end 20. As described in greater detail belowwith regard to FIGS. 16-22, one of the ends 18, 20 of the sectioningelement 16 may be movable relative to the shaft 12, while the other ofthe ends 18, 20 of the sectioning element 16 may be fixed relative tothe shaft 12. For example, the second end 20 of the sectioning element16 may be fixed relative to the shaft 12 and the first end 18 of thesectioning element 16 may be slideable relative to the shaft 12. Thesecond end 20 may be connected to the shaft 12 or to other structure bycrimping, welding, adhesives, mechanical interlocks, or any othersuitable structure or method. In some embodiments, the sectioningelement 16 is a wire with a circular, oval or other atraumaticcross-section. In other embodiments, the sectioning element 16 is astrap. As used in this document, a strap is a structure that is widerthan it is thick, as viewed longitudinally.

In the first, retracted configuration, where the distal end of thesectioning element 16 extends distally out of the shaft 12, thesectioning element 16 is sized and shaped to pass through a standardcorneal incision 4 without damaging the eye 1. The corneal incision 4 isgenerally 3.5 mm or less in width and made with a small knife. Thus, theouter diameter of the shaft 12 advantageously is 3.5 mm or less. Where adifferently-sized incision 4 is used, a different outer diameter ofshaft 12 may be used, keeping in mind that it is most desirable to formthe incision 4 as a line 5 mm or less in length. In other embodiments,the sectioning element 16 is positioned completely within the lumen 14of the shaft 12 such that it is within the inner diameter of the shaft12 as the shaft 12 is inserted through the incision 4, and is thenextended out of the shaft 12 once in the eye. Alternatively, additionalcomponents may be used to sheathe the sectioning element 16 duringinsertion through the corneal incision 4. The device can include athin-walled, retractable sleeve or sheath that restricts movement of thesectioning element 16 away from the longitudinal axis A of the deviceduring certain times of use (i.e. during insertion, expansion and/orprior to splay of multiple sectioning elements relative to one another).In some implementations, a tapered piece may be positioned on the distalend of the shaft 12 that gradually tapers from the end of the shaft 12down to a smaller cross section such that it can aid insertion throughthe corneal incision 4. The tapered piece can also cover the sectioningelement 16 to constrain it during insertion. The tapered piece canfurther have a slit in the front that the sectioning element 16 canextend through or tear open once it has passed through the incision 4.

According to some embodiments, the sectioning element 16 is fabricatedfrom of a flexible or superelastic material, such as nickel-titaniumalloy, which allows the sectioning element 16 to bend and flex as it isinserted into the eye 1 through the corneal incision 4. The sectioningelement 16 can also be formed from other materials such as a polymerrather than metal. In these embodiments, the constricted shape of thesectioning element 16 may be larger in one or more dimensions than thecorneal incision 4, and flexes to pass through the incision 4 as theshaft 12 moves toward the capsulorhexis 10. Alternatively, thesectioning element 16 may not have a first, retracted configuration, andmay be inserted through the incision 4 in the same configuration that islater utilized to engage the lens 8. In such embodiments, the sectioningelement 16 compresses as it passes through the corneal incision 4 andthen re-expands once it enters the eye 1. In still other embodiments,the sectioning element 16 may not have a first, retracted configuration,and may be inserted through the incision 4 in a larger configurationthan is later utilized to engage the lens 8. In still other embodiments,the sectioning element 16 may be hooked, rotated, or otherwise insertedthrough the corneal incision 4 in any number of methods.

Referring to FIG. 4, the sectioning element 16 or elements are pusheddistally relative to the lumen 14 of the shaft 12. As set forth above,one end 20 of the sectioning element 16 may be fixed, such that theother end 18 of the section element 16 is pushed distally relative tothe lumen 14 of the shaft 12. As a result, the sectioning element 16moves from a first, retracted configuration to a second, captureconfiguration.

The sectioning element 16 may be fabricated from any suitable material.For example, as discussed above, shape memory materials such asnickel-titanium alloy may be used to allow the sectioning element 16 tomove to its predefined shape in the second, expanded configuration, witha high amount of elasticity. In one embodiment, the nickel-titaniumalloy may be used in its superelastic condition, where thenickel-titanium alloy transforms its crystal structure to move from thefirst, retracted configuration to the second, expanded configuration. Inother embodiments, the sectioning element 16 is fabricated fromnickel-titanium alloy that is shape set to move from the first,retracted configuration to the second, capture configuration uponreaching a transition temperature that is above room temperature butbelow body temperature. The sectioning element 16 fabricated fromnickel-titanium alloy thus may enter the eye at room temperature belowits transition temperature such that it will hold a constricted shape.As the sectioning element 16 is placed into the eye 1 and allowed towarm to body temperature, the nickel-titanium alloy may become warmerthan its transition temperature and begin to return to its predefinedsecond, expanded configuration. This shape change may happen over aperiod of time that allows the surgeon to place the sectioning elementinto the capsular bag 6 and orient it while the shape changes such thatthe loop can define a sectioning plane through the lens. Alternatively,any other number of biocompatible materials may be considered such asstainless steel or non-metal polymer materials. In some embodiments, thenickel-titanium alloy may be warmed actively by the surgical device 40,in which case the transition temperature of the sectioning element 16may be selected to be greater than room temperature but less than atemperature that would damage the tissue of the capsular bag 6 or othertissue of the eye 1. Other shape memory materials such as shape memoryplastics may be utilized instead of nickel-titanium alloy.Alternatively, any other number of biocompatible materials may beconsidered such as stainless steel, titanium, silicone, polyimide,PEBAX® polyether block amide, nylon, polycarbonate, or any othersuitable material. Furthermore, multiple materials joined end to end orin laminated layers or concentric tubes of material may be used.

Referring also to FIGS. 1 and 4, in the second, expanded configuration,the sectioning element 16 is specifically shaped for lens capture.According to some embodiments, the second, expanded configuration is apreset shape of the sectioning element 16, such as through the use ofelastic or superelastic materials to fabricate the sectioning element.

As seen most clearly in FIG. 4, in the second, expanded configuration,the sectioning element 16 approximates an irregular loop that isgenerally shaped like the cross-section of a lens 8, and that is shapedand sized to surround the lens 8 within the capsular bag 6. As set forthabove, in some embodiments, the sectioning element 16 is fabricated froma length of round wire. The second, expanded configuration of thesectioning element 16 has a merging point 22 where the first end 18 andsecond end 20 of the sectioning element 16 merge back together, forminga shape with a perimeter so that the device 40 approximates a closedloop 21. The “merging” refers to placing the first end 18 and second end20 of the sectioning element 16 into proximity with one another. Themerging point 22 may be located at or in proximity to the distal end ofthe shaft 12. In the second, expanded configuration, the sectioningelement includes a distal portion 28 that extends distal to the mergingpoint 22 and a proximal portion 26 that extends proximally to themerging point 22. The merging point 22 in this exemplary embodiment isat a point above the surface of the lens and within the circle definedby the capsulorhexis 10 at the top of the capsular bag 6. In someembodiments, the proximal portion 26 of the sectioning element 16 mayinclude a tight radius bend 24 as shown in FIG. 1. The tight radius bend24 bends the second end 20 of the sectioning element 16 proximally suchthat the second end 20 extends proximally from the merging point 22.Alternatively, the sectioning element 16 may take a different path toachieve this path transition without such a sharp radius bend. Forexample, paths that are outside of the normal plane of FIG. 1 such ascurves or oscillations may be incorporated to reduce the overall bendradius of the proximal portion 26 of the sectioning element 16. This mayimprove the ability of the sectioning element 16 to change shape intoother smaller constricted configurations as will be discussed below.

The first end 18 and/or second end 20 is pushed out of the lumen 14 ofthe shaft 12, while the other end is fixed relative to the shaft 12, asdescribed above. Alternatively, both ends 18, 20 of the sectioningelement 16 are movable relative to the shaft 12 and configured to sliderelative to the lumen 14 of the shaft 12. Alternatively, the shaft 12may be the sliding component while the sectioning element 16 remainsstationary. As the end or ends 18, 20 (sometimes referred to as “legs”)are pushed outward from the lumen 14, the sectioning element 16transitions to the second, expanded configuration. As the sectioningelement 16 transitions, the tight radius bend 24 allows the proximalsection of the sectioning element to extend proximally from the distalend of the shaft 12, at a location spaced from and to one side of (i.e.off-set from) the longitudinal centerline of the lumen 12 in thedirection toward the capsular bag 6. In this way, the sectioning element16 is able to extend downward through the capsulorhexis 10 and expand toa length within the capsular bag 6 that is greater than the diameter ofthe capsulorhexis 10, as seen in FIG. 1. According to some embodiments,the tight radius bend 24 results in the second end 20 having an angle ofat least 120 degrees relative to the longitudinal centerline of theshaft 12, and relative to the distal direction, as seen in FIG. 1. Boththe distal portion 28 and the proximal portion 26 of the sectioningelement 16 in the second, expanded configuration are gently curved andgenerally approximate the size and shape of the lateral sides of thecapsular bag 6, in order to enter the capsular bag 6 without causingdamage (e.g., such as a capsular tear or hole, over-stretching thecapsular bag, or damaging the inner surface of the capsular bag tissue).

Referring also to FIG. 2, the shape of the sectioning element 16 in thesecond, expanded configuration forms a plane that is generally flat orhorizontal with respect to the top lens surface, according to someembodiments. Referring back to FIGS. 1 and 3, with the correctorientation, the sectioning element 16 is held such that it opensthrough the capsulorhexis 10 into the capsular bag 6. As the sectioningelement 16 continues to expand, the plane formed by the sectioningelement 16 can be rotated so that the sectioning element traverses aspace between the capsular bag and the lens. The plane includes thelongitudinal axis of the lumen 14 of the shaft 12. Alternately, theshape of the sectioning element 16 in the second, expanded configurationis a more three-dimensional shape that does not lie in a single plane.For example, the sectioning element 16 may oscillate in and out of aflat plane, or may be substantially curved out of a flat plane in onedirection or another. The rotation may be accomplished by manualrotation of the shaft 12 of surgical device 40 by the user, or may beaccomplished by integrated mechanisms within the surgical device 40, asdescribed in greater detail below. Referring also to FIG. 4, thesectioning element 16 has proceeded most of the way from the first,retracted configuration to the second, expanded configuration, and hasbeen rotated partially relative to the lens 8. The sectioning element 16may be rotated such that the shape plane is primarily vertical or to anynumber of other angles. Mechanisms and methods for producing suchrotation are described in greater detail below. Additionally, multiplesectioning elements 16 may be used that rotate to a variety of angles.In other embodiments, the rotation does not occur until the sectioningelement 16 transitions to the second, expanded configuration. Accordingto some embodiments, rotation begins while the sectioning element 16transitions to the second, expanded configuration. For example, rotationmay begin once an open area 46 of the loop and within the sectioningelement 16 expands to a size in which a 5-6 mm chord extends across theopen area 46 between two points on the proximal portion 26 and thedistal portion 28. As another example, rotation may begin when the chordis longer than, or shorter than 5-6 mm.

The second, expanded configuration of the sectioning element 16 may begenerally ovular in shape, referring to FIG. 1, with a width 7.0 mm-15mm and a height of 3.0-10 mm, according to some embodiments. Accordingto other embodiments, the width of the sectioning element 16 may be4.0-20 mm with a height of 1.0-15 mm. In some embodiments the size ofthe second, expanded configuration of the sectioning element 16 may beintentionally smaller than the size of the lens at certain areas oralong the entire profile. This may improve the ability of the sectioningelement 16 to remain close to the lens 8 and reduce interaction with thecapsular bag 6. For example, the second, expanded configuration of thesectioning element 16 may be 12 mm wide and 4.0 mm high. This may allowclearance between the sectioning element 16 and the lens 8 at the widthof the oval while maintaining interference along the height of the ovalthat may reduce the likelihood of damaging the posterior surface of thecapsular bag 6. That is, by configuring the second, expandedconfiguration of the sectioning element 16 to engage a portion of lens8, rather than move to a position in which it encircles the thickestpart of the lens 8, the sectioning element 16 is sized smaller, andengages less of the capsular bag 6, than a configuration in which thesecond, expanded configuration of the sectioning element 16 is able toencircle the thickest part of the lens 8. In other embodiments, thesecond, expanded configuration of the sectioning element 16 ispredefined to have a generally specific clearance around the lens 8.According to some embodiments, the second, expanded configuration of thesectioning element 16 has a different shape than generally oval.

The sectioning element 16 may have features or geometry that furtherprevents the element from damaging the capsular bag. For example, thesectioning element 16 is a round wire of sufficient diameter to reducethe likelihood of tearing or damaging the capsular bag 6, according tosome embodiments. The diameter of that round wire may be 0.004″-0.012″but may also be any size that prevents excessive stress from beingplaced on the capsular bag 6, such as 0.001″-0.030″ diameter.Alternatively, the profile of the sectioning element 16 may be ovularwith a larger width or height, or may be a strap, to further distributethe force of the sectioning element 16 on the capsular bag 6 over alarger surface area, thereby reducing or eliminating areas of highpressure exerted on the capsular bag 6 by the sectioning element.

In some embodiments, portions of the outer surface of the sectioningelement 16 may be coated to improve certain aspects of the device. Forexample, as discussed in greater detail below, the sectioning element 16traverses a space between the capsular bag 6 and the lens 8. As thesectioning element 16 moves between these anatomical structures it maybe advantageous to have a more hydrophilic or hydrophobic surface so thesectioning element 16 rotates and moves more freely. In one embodiment,the sectioning element 16 may be coated with a hydrophobic material suchas a fluoropolymer; for example, PTFE. A coating can be added throughdip coating, plasma vapor deposition process, heat shrink sleeves, orany other suitable method. The coating can reduce the friction betweenthe sectioning element 16, and the lens 8 and/or capsular bag 6, toallow the sectioning element 16 to move more freely. Other methods ofreducing the friction may include using mechanical abrasion, plasmatreatments, or any other suitable method. Alternatively, the sectioningelement 16 may be coated with other materials such as activepharmaceutical agents that are configured to release into they duringthe procedure. For example, a steroid like triamcinolone may be added tothe surface of the sectioning element 16 such that during the procedureit releases into the eye. Any other number of coatings and drugs may becontemplated.

The sectioning element 16 may be constructed with any other suitablegeometries or materials. In an exemplary embodiment, the sectioningelement 16 is a round wire. The wire is configured to bluntly traverse aspace between the lens 8 and the capsular bag 6. The wire can havevarious sizes or diameters along the length of the sectioning element16. Alternatively, the sectioning element 16 may be any number of otherprofiles. For example, the sectioning element 16 could be a tube, aribbon, a strap, a wire with a hexagonal profile, or any other number ofsuitable shapes. In addition, the profile of the sectioning element 16could change along its length. For example, the sectioning element 16may include one or more padded areas along its profile where damage tothe capsular bag 4 is of particular concern. The padded areas mayinclude different materials, such as but not limited to soft elastomericmaterials like silicone that are bonded or coated onto appropriate areasof the sectioning element 16. The padded areas may distribute the forceover a larger area, and provide a softer and more atraumatic interfaceagainst the capsular bag 6. In other embodiments, the padded areas aregeometry profile changes of the sectioning element in certain areas. Forexample, areas that are flared out or broadened, even if comprised ofthe same material, distribute the force over a larger area.Additionally, the stiffness or flexibility of the sectioning element mayvary over the sectioning element 16 by changing the material thicknessor wire diameter in certain areas. Alternatively, sleeves or othermaterials may be added to the sectioning element 16 to increasestiffness locally in certain areas. In still other embodiments, thesectioning element 16 may have cuts or ribs along its length that changeits flexibility or stiffness in certain areas.

In other embodiments, the shape of the sectioning element 16 in thesecond, expanded configuration is not predetermined. Instead shape ofthe sectioning element 16 in the second, expanded configuration isdefined by the material or geometric properties of the sectioningelement 16, engaged with the lens 8. The sectioning element 16 may besufficiently flexible, elastic, soft, or blunt along its length, whilemaintaining sufficient stiffness to allow for rotation to engage thelens 8, such that minimal force is applied to the capsular bag 6 evenwhen the sectioning element 16 is within the capsular bag 4 and fullyopened. In other embodiments, the sectioning element 16 may be a softelastomer such as silicone that may be sufficiently soft and largeenough in diameter so that the sectioning element 16 does not placeexcessive force onto the capsular bag 6. In still other embodiments, thesectioning element 16 may be sufficiently blunt along certain portionsand edges such that the force applied to the capsular bag 6 isdistributed over a larger area and therefore the tearing pressure may bereduced. In still other embodiments, the sectioning element 16 may becomprised of a linkage of multiple elements, for example a chain-likestructure, allowing for flexible movement between the multiple elements.In still other embodiments, the sectioning element 16 may have slitsalong portions of its length that locally may increase its flexibility.For example, the sectioning element 16 may include a tube with cutoutsalong its length at areas where the capsular bag 6 may come in contactwith the sectioning element 16 such that these areas are more flexibleand therefore are less prone to putting excessive force onto thecapsular bag 6. In still other embodiments, portions of the sectioningelement 16 in the second, expanded configuration are not predeterminedin shape, while other portions of the sectioning element 16 arepredetermined in shape. For instance, a portion of the sectioningelement 16 anterior to the lens may be fabricated from a shape memoryround wire that is shape-set to a predefined shape that aids in guidingthe sectioning element 16 into the eye. For example, such a portion caninclude the tight radius bend 24 of the proximal portion 26. A portionof the sectioning element 16 posterior to the lens 8 may be fabricatedfrom a different, more-flexible material that more easily conforms tothe shape of the eye. In this way, the portion of the sectioning element16 in the second, expanded configuration that allows for insertion ofthe sectioning element through the capsulorhexis, including the tightradius bend, are anterior to the lens 8, and the portion of thesectioning element 16 in the second, expanded configuration thatcontacts the capsular bag 6 is composed of more-flexible material evenless likely to damage the capsular bag 6.

According to some embodiments, additional guide tubes or components mayalign or direct the path of the sectioning element 16 through thecapsulorhexis 10 and/or around the lens 8. For example, in embodimentswhere the sectioning element 16 in the second, expanded configurationdoes not have a predefined shape, a guiding element may exist alongareas of the distal portion 28 or proximal portion 26 of the sectioningelement 16 to constrain it into a particular shape. A tube may extendfrom the merging point 22 in the direction of the distal portion 28, andthe tube may concentrically constrain the flexible sectioning element 16such that it more or less follows a desired path during insertion intothe capsular bag 6 and placement around the lens 8. The guiding tube maythen be retracted, leaving the flexible sectioning element 16 in placearound the lens 8.

In still other embodiments, the predefined shape of the sectioningelement 16 in the second, expanded configuration may be created duringany part of the surgical procedure. For example, the surgeon may useimaging techniques to measure anatomical features of the eye such as thelens 8 or capsular bag 6. The surgeon may then use this information toor change a shape of the sectioning element 16. Alternatively, a pieceof equipment such as a forming die or an automated wire forming machinedmay be used in conjunction with the measured data to change the shape ofthe sectioning element 16 in the second, expanded configuration. In oneembodiment, the surgeon uses an imaging modality such as OCT to performa measurement of the lens 8, and then this information is provided to anautomated wire forming station that creates a custom sectioning element16 for the patient. In still other embodiments, the surgeon may add orchange a shape of the sectioning element 16 while at least a portion ofthe sectioning element 16 is within the eye. For example, the surgeonmay begin to place the sectioning element 16 into the capsular bag 6 anddetermine that its shape may be improved. The surgeon may then insert aseparate tool such as forceps into the eye or use an integrated toolassociated with the shaft 12 to add or change a shape of the sectioningelement 16.

According to some embodiments, a fluid is introduced between thecapsular bag 6 after the capsulorhexis 10 is made, such that a space iscreated between the lens 8 and capsular bag 6 in at least some areas.This may be referred to as fluid dissection, hydro dissection or spacecreation. According to some embodiments, the fluid creates a space forthe sectioning element 16 in the second, expanded configuration to berotated within the capsular bag 6 and surround the lens 8. In anexemplary embodiment, fluids such as viscoelastic hyaluronic acid orsaline may be injected since these materials are commonly used duringocular surgery, well-tolerated within the eye, and readily available.One or more other or additional fluids may be introduced, such as dyedfluids, pharmaceutical liquids like steroids, drug loaded fluids, bioabsorbable fluids, lubricants, hydro gels, microspheres, powderedsubstances, fluorescent contrast, liquid foams, or any other suitablefluid. Additionally, one or more gases additionally or instead may beintroduced, such as air, oxygen, argon, nitrogen, or the like.Alternatively, in other embodiments a fluid space may not be requiredbetween the lens 8 and the capsular bag 6, and the sectioning element 16may perform a mechanical dissection or blunt dissection of the lens 8and capsular bag 6 as it is rotated about the lens 8. Fluid dissectionand blunt dissection may be done in combination with one another orseparately. The fluid may be injected through a cannula or a needle intothe capsular bag 6 using a separate instrument. According to otherembodiments, provisions for fluid dissection may be incorporated intoelements of the surgical device 40, such as the sectioning element 16.For example, the sectioning element 16 may be fabricated as a flexibletube with a plurality of holes along its length that allow for thepassage of fluid therethrough. In such an embodiment, fluid may beintroduced into the lumen of the sectioning element 16 and then flow outof the plurality of holes. This may improve the ability of thesectioning element 16 to pass between the capsular bag 6 and the lens 8because the fluid may be introduced through the sectioning element 16continuously or at discrete points in time when dissection is needed. Instill other embodiments, the fluid injection may be incorporated inother aspects of the surgical device 40. For example, fluid may bedelivered via the lumen 14 of the shaft 12. Alternatively, a componentseparate from the shaft 12, such as a telescoping tube or other tube,may be connected to the shaft 12 to provide for fluid introduction. Insome embodiments, the fluid that is infused through a component of thedevice, such as the shaft 12 or the sectioning element 16, may be usedfor other surgical purposes. For example, fluid may be infused throughthe shaft 12 to maintain the chamber of the eye 1 without the need for aseparate cannula or without the need for a viscoelastic substance.Irrigation and aspiration may be accomplished through a single componentor through multiple separate components. For example, fluids such assaline may be irrigated into the eye through a lumen of an embodiment ofthe sectioning element 16, as described above, and aspirated through thelumen of the shaft 12. Other irrigation or aspiration techniques may beperformed, according to some embodiments.

Referring to FIG. 5, the sectioning element 16 has been fully extendedto the second, expanded configuration, and has been rotated about thelongitudinal axis of the shaft 12 and/or otherwise rotated or moved toan orientation within the capsular bag 6 in which the sectioning element16 surrounds the lens 8 without exerting excessive force onto thecapsular bag 6. The sectioning element 16 is then used to cut the lens 8by tensioning one or both ends 18, 20 of the sectioning element 16, suchas by retracting one or both ends 18, 20 through the lumen 14 of theshaft 12. The sectioning element 16 may be moved in the opposite manneras set forth above for expanding the sectioning element 16 from thefirst to the second configuration, in order to compress and cut the lens8. As the sectioning element 16 is tensioned, it exerts an inward forceon the lens 8 and begins cutting and/or fragmenting it due to the forceapplied to the lens 8 across the small surface area of the thin diametersectioning element 16. The sectioning element 16 continues to betensioned until the lens 8 is partially or fully sectioned. In someembodiments the sectioning element 16 is tensioned until the lens 8 isfully sectioned. In other embodiments, tensioning of the sectioningelement 16 only partially fragments the lens 8, and the remainder of thelens 8 can be fragmented by repeating the use of the sectioning element,or with additional tools. Referring to FIG. 6, the fragmented lens 8 isshown within the capsular bag 6. The section plane is primarilyvertical, but it should be appreciated that any number of angles andorientations may exist for the cutting path of the sectioning element16. Referring to FIG. 7, the lens is shown with the capsular bagremoved.

In some embodiments, the surgical device 40 may incorporate multiplesectioning elements 16, as described below, to create multiple lensfragments at one time. For example, the multiple sectioning elements 16may form a mesh that is capable of cutting the lens 8 into a multitudeof fragments; the sectioning elements 16 may be at oblique or acuteangles relative to one another such that they form a crisscross pattern.In other embodiments, the surgical device 40 may be used successively onthe lens 8. For example, after a single section is created the lens 8(or the sectioning element 16) can be rotated 90 degrees such that thefirst section plane is now perpendicular to the delivery device plane.The sectioning element 16 can then be reinserted into the capsular bag 6as described above, and used to create a new section across the two lensfragments that creates four fragments in total. The process may berepeated for as many times as necessary to create any number of lensfragments of any desired size. The final desired size of the lensfragments may depend on method of extraction from the eye 1. In someembodiments, phacoemulsification additionally may be used in thecapsular bag 6 to remove the lens fragments. This may be particularlyuseful in difficult or hard cataracts, where full lens fragmentationincreases the surface area and decreases the size of fragments that areto be emulsified by phacoemulsification. In other embodiments, the lensfragments may be extracted as described below.

In some embodiments, the lens fragments may be pushed out of thecapsular bag 6 by introducing fluid into the capsular bag 6 under slightpressure. The fluid flow and/or pressure may move the lens fragmentsinto the anterior chamber of the eye 1, such that other tools andmethods for extracting the lens may be utilized. For example, forceps orgrasping tools may be used to grab the lens fragments and pull them outof the eye 1 through the corneal incision 4. In some embodiments, thesectioning element 16 may be used to snare the lens fragments and pullthem out of the eye 1. The sectioning element 16 may be returned to thesecond, expanded configuration and placed around a lens fragment. Thesectioning element 16 may then be tensioned or otherwise closed untilthe lens 8 is held within of the sectioning element but the lensfragment is not cut. The lens fragment can then be pulled out of the eye1 with the sectioning element 16. To ensure that the lens 8 is not cutby the sectioning element 16, additional components may be used such aspads, straps, or strips with a larger surface area that grip the lensfragment rather than cutting it. These components can be extended fromthe shaft 12, or may be separate components that are inserted into theeye 1 through the incision 4 and attached to the sectioning element 16.

Referring to FIGS. 8-9, one embodiment of the surgical device 40includes two sectioning elements 16 extending from the distal end of ashaft 12, with a handle mechanism 42 attached to the proximal end of theshaft 12. Referring also to FIG. 15, two sectioning elements 16 areshown in the first, retracted configuration at the distal end of theshaft 12. The handle 42 has two sliders 44 a, 44 b slideablelongitudinally, which are connected to the two sectioning elements 16 asdescribed below. The sliders 44 a, 44 b in this initial configurationare in their retracted proximal location. The shaft 12 and sectioningelements 16 in the first, retracted configuration are inserted throughan incision 4 in the cornea 2 toward a capsulorhexis 10, as describedabove. As used in this document, the term “handle” includes both handlesconfigured for manual gripping and actuation by a surgeon, as well as arobotic handle that is coupled to a surgical robot and configured forrobotic control and actuation.

Referring also to FIGS. 16-17, one embodiment of a handle 42 of thesurgical device 40 is shown in cutaway in a configuration correspondingto the first, retracted configuration of the sectioning elements 16. Aslider 44 is slideable along the top surface of the handle 42. A finger48 extends from the slider 44 into the handle 42 through a slot in thetop surface of the handle 42. The finger 48 is coupled to a helical cam50 or other cam structure, located proximal to the finger 48, that islongitudinally fixed to the finger 48 but that is free to rotate axiallyrelative to the finger 48. This may be accomplished mechanically throughan engagement pin, collar, or other suitable mechanism. A cam path 52 isdefined in the surface of the helical cam 50. The helical cam 50 isconfined within a chamber inside the handle 42 that allows the helicalcam 50 to slide longitudinally but not move substantially radially. Anose 56 extends distally from the finger 48 and is rotatable relative tothe finger 48. Advantageously the nose 56 is rotationally fixed to thehelical cam 50. In some embodiments, the nose 56 is simply the distalend of the helical cam 50. A retraction spring 58 is positioned betweenthe finger 48 and the front passage 60 out of the handle 42, acting topush the finger 48 toward the first, retracted configuration. Theproximal end of the retraction spring 58 may be centered on and engagethe nose 56. The proximal end of the first end 18 of the sectioningelement 16 may be fixed to the nose 56 in any suitable manner, such asby wrapping around the nose, friction fitting, welding, soldering, or bypressure fitting. Alternately, the proximal end of the first end 18 maybe fixed to the finger 48. A cam post 62 is defined in and/or fixedrelative to the handle 42, and engages the cam path 52. As the helicalcam 50 translates relative to a remainder of the handle 42, the cam post62 remains in the same place on the handle 42. Where two sectioningelements 16 are used, two such assemblies as described above (the slider44, finger 48, cam 50, nose 56, retraction spring 58 and connection tothe first end 18 of the sectioning element 16) are utilized side-by-sidewithin the handle 42. Such assemblies may be identical to one another,may be lateral mirror-images of one another, or may vary from oneanother in other ways that allow substantially the same assembly tooperate two separate sectioning elements 16 in the manner describedbelow. The description of the motion of the sliders 44 a, 44 b and thesectioning elements 16 are the same for both sliders 44 and sectioningelements 16 unless otherwise noted, and the descriptions of the two areinterchangeable unless otherwise noted.

Referring to FIG. 10, one of the sectioning elements 16 is transitionedto the second, expanded configuration by sliding the correspondingslider 44 b distally. One end 20 of the sectioning element 16 may beconnected to the shaft 12, handle 42, or other structure fixed relativeto the handle 42, and maintained in a fixed position while the first end18 is configured to translate and rotate with the moving elements withinthe handle 42. As set forth above, the first end 18 is attached to thenose 56. Referring also to FIG. 18, as the slider 44 translatesdistally, the finger 48 compresses the retraction spring 58, moves thenose 56 distally, and pulls the helical cam 50 distally. The retractionspring 58 is compressed and imparts a proximal force on the finger 48.If the user releases the slider 44, the slider 44, finger 48, andmechanisms translationally fixed to the finger 48 are pushed distallytoward the initial position of the slider 44. As the slider 44 advancesdistally, the helical cam 50 translates within the handle 42. The campath 52 may be substantially longitudinal during this first segment ofmotion of the slider 44, such that engagement between the cam path 52and cam post 62 does not cause rotation of the helical cam 50.Therefore, the sectioning element 16 remains in substantially the samerotational orientation relative to the longitudinal axis of the shaft12. As the slider 44 advances distally, it pushes the first end 18 ofthe sectioning element 16 distally. As a result, the sectioning element16 changes shape to the second, expanded configuration, in the samemanner as described above with regard to FIGS. 1-4.

Referring also to FIG. 11, the slider 44 may be further advanceddistally after the sectioning element 16 changes shape to the second,expanded configuration. The cam path 52 engages the cam post 62 torotate the helical cam 50, as seen in FIGS. 18-20. The amount of distalmotion of the slider 44 controls the amount of rotation of the helicalcam 50. In this way, linear motion of the slider 44 is converted torotary motion of the sectioning element 16. Because the helical cam 50and the nose 56 are rotationally fixed to one another, rotation of thehelical cam 50 causes rotation of the nose 56, and thus rotation of thesectioning element 16 in the second, expanded configuration. Thesectioning element 16 rotates, and the plane defined by the shape of thesectioning element 16 correspondingly rotates. The sectioning element 16is rotated from its initial position, which may be substantiallyparallel to a plane defined by the edges of the capsulorhexis 10, to aposition that is approximately within 0-40 degrees from a verticalorientation. During this rotation, the sectioning element 16 movesbetween the capsular bag 6 and the lens 8, capturing the lens 8 in theopen area 46 within the perimeter of the sectioning element 16. Thesectioning element 16 may not engage the capsular bag 6 and/or lens 8substantially, or may be configured to engage either the lens 8 or thecapsular bag 6. Alternately, the sectioning element 16 may cause a bluntdissection between the capsular bag 6 and the lens 8.

Referring also to FIG. 20, the slider 44 is moved fully forward and therotation of the helical cam 50 and sectioning element 16 is complete.The sectioning element 16 surrounds the lens 8 within the capsular bag6, and is configured to apply an inward cutting force relative to thelens 8, in the manner described above with regard to FIGS. 4-5.

Referring also to FIGS. 12-13, a second sectioning element 16 then maybe deployed to a second, expanded configuration, and rotated intoposition to surround the lens 8, in the same manner as described abovewith regard to FIGS. 9-11 and 16-20. Referring also to FIG. 14, bothsectioning elements 16 engage the lens 8, such that when the sectioningelements 16 are tensioned or otherwise closed, the sectioning elements16 will cut the lens 8 into three partially- or fully-separatefragments. Referring also to FIG. 21, the tensioning may be provided bysliding the sliders 44 proximally, thereby pulling the first end 18 ofeach sectioning element 16 proximally and tensioning it. In someembodiments, the proximal force exerted on the finger 48 by theretraction spring 58 may be sufficiently large to cut the lens 8 withoutthe application of additional force by the user. In other embodiments,the user provides additional force that fragments the lens 8. This maybe necessary especially for hard or difficult cataracts. Each sectioningelement 16 engages the posterior surface of the lens 8 along a linespaced apart from the other sectioning element 16, and engages theanterior surface of the lens 8 along substantially the same line,according to some embodiments.

In FIG. 22, the slider 44 is moved proximally to return to the originalposition. The sectioning element 16 is rotated back to its originalplane of insertion, and then retracted toward the shaft 12. Referringalso to FIG. 15, the sectioning elements 16 may return substantially totheir initial configuration after sectioning the lens. The cam path 52of the helical cam 50 may be a closed loop as shown. Alternately, thecam path 52 may be a one-way path wherein the slider 44 must betranslated fully distally and then proximally to move it to the originalposition. In some embodiments, one-way latches or levers may beincorporated into the cam path 52 that prevent the helical cam 50 fromrotating or moving in certain directions, and may be included atdiscrete positions of the cam path 52 or along the entire cam path 52.

According to some embodiments, the sectioning elements 16 may beconfigured to move synchronously with the actuation of a single slider44, rather than each sectioning element 16 being coupled to a differentslider 44 a, 44 b as described above. If so, the sectioning elements 16may be configured to expand, open and/or rotate at the same time.Alternately, the rotation of the sectioning elements 16 may be staggeredsuch that one sectioning element 16 opens first and rotates first beforethe other sectioning element 16. This may be accomplished by associatinga different cam path 52 and cam post 62 with each sectioning element 16.In still other embodiments, two sliders 44 a, 44 b can be configuredsuch that a left slider 44 b will move both sliders 44 forward, but theright slider 44 a will only move the right slider 44 a forward (or viceversa). The right slider 44 a may be configured to move both sliders 44a, 44 b backward and the left slider to move only the left slider 44 bbackward. Thus, the user may decide whether to move the sliders 44 a, 44b independently or synchronously.

According to some elements, the sectioning elements 16 are rotated inthe same direction. For example, the first sectioning element 16 opensand is then rotated into the capsular bag 6 in a clockwise direction.The second sectioning element then opens and is also rotated into thecapsular bag 6 in a clockwise direction. In this embodiment, the firstsectioning element 16 may rotate to an angle 10-40 degree beyond avertical plane, and the second sectioning element 16 may rotate to anangle 10-40 degree less than a vertical plane.

In still other embodiments, one or more additional or differentmechanisms may be used to deploy the sectioning elements 16. Forexample, a scroll wheel advancing mechanism or other rotating mechanismcould be used to deploy one or both sectioning elements 16. In someembodiments, the movement by the user is geared up or down to themovement of the sectioning element 16 such that moving a given amount ofthe user interface components moves the sectioning element 16 a greateror lesser amount through the use of gears, scaled pulleys or any othernumber of components. In some embodiments, certain parts of the surgicaldevice 40 may be mechanically powered through components such as motors,linear motors, pneumatics, hydraulics, magnets, or the like. Thesurgical device 40 may be incorporated as a part of one or more largerrobotic assemblies. For example, a robotic device that is configured toperform a cataract procedure may include an embodiment of the surgicaldevice 40. This may allow surgeons to perform parts of the describedmethod robotically. In some embodiments this may allow for alternatetechniques and methods such as approaching the capsular bag 4 throughthe sclera. According to some embodiments, at least inserting a shaft 12having a lumen 14 therethrough, through the corneal incision 4 towardthe capsulorhexis 10, and extending a sectioning element 16 out of thedistal end of the lumen 14, to cause the sectioning element 16 to bendaway from the axis of the shaft 12 through the capsulorhexis 10, expandto a size greater than the capsulorhexis 10, and capture at least a partof the lens 8, are performed under robotic control.

In some embodiments, the sectioning element 16 need not approximate aloop initially as it is placed into the capsular bag 6. For example, thesectioning element 16 may be a single piece of round wire that is fedinto the capsular bag 6 from the shaft 12, without doubling back onitself to form a loop. In such an embodiment, the distal tip of thesectioning element 16 is blunt to prevent puncture or damage to tissuewithin the eye 1. As the distal tip of the sectioning element 16 reachesthe wall of the capsular bag 6, it may be configured to bend with eithera predefined bend in its structure, or by tracking along the innersurface of the capsular bag 6. The sectioning element 16 may thentraverse a space between the lens 8 and the capsular bag 6 such that itgoes around a circumference of the lens 8. The sectioning element 16 maythen come back into the view of the user into the top portion of thecapsular bag 6 where the user can grab the sectioning element 16 withfeatures on the handle 42 such as grippers, or with a separate toolentirely. At this point, the sectioning element 16 surrounds the lens 8within the capsular bag 6 and approximates a loop. As one or both endsof the sectioning element 16 are tensioned and/or pulled, an inwardcutting force is applied to the lens 8 such that it is fragmented. Thesectioning element 16 of this embodiment may have a cross-section thatallows it to bend preferentially in certain directions more easily thanothers, such that the sectioning element 16 can bend as necessary totrack around the lens 8 but still follow a suitable path around the lens8 without going off track into tissue. This may include the use of apreferred bending moment cross-section like an “I” beam that bendspreferentially about certain planes. Alternatively, a tube with cutoutsto allow bending may be configured to bend in certain planes by placingthe cuts in this plane. Therefore, the sectioning element 16 may bendaround the lens 8, primarily in a distal-to-proximal manner. This mayimprove the ability of the sectioning element 16 to traverse a desiredgeneral path relative to capsular bag 6 and lens 8. In some embodiments,the sectioning element 16 may be entirely flexible such that its distaltip is unconstrained to travel in any predefined path. The distal tipmay be configured to include a magnet or electromagnetic components towhich a force can be applied to with an external electromagnetic field.An external device may then be used to control the location of thedistal tip of the sectioning element 16 such that it may be guidedaround the capsular bag 6 along a desired path. Any number of differentpaths or fragmentation planes may be contemplated with this embodiment.The surgical device 40 may incorporate various imaging modalities inorder to create a desired path for the distal tip of the sectioningelement 16 that does not damage the capsular bag 6.

In some embodiments, the sectioning element 16 may bifurcate intomultiple portions and/or multiple loops. For example, in the initialconfiguration, the sectioning element 16 may have a shape and profile asdescribed above. However, when transitioned to the second, expandedconfiguration, the sectioning element 16 may bifurcate along its lengthinto two elements that may have the same or similar shapes, or differentshapes, each surrounding the lens 8 in whole or in part. This may allowthe sectioning element 16 to cut the lens 8 into multiple fragmentswithout using two separate sectioning elements 16.

In some embodiments, one or both of the sectioning elements 16 may beconfigured to apply one or more types of energy to aid in the bluntdissection or fragmentation of the lens 8. For example, one or both ofthe sectioning elements 16 may include one or more portions configuredto be heated through the use of electrically resistive wire that becomeshot as current is run through it. The increased temperature may improvethe separation of the capsular bag 6 and the lens 8 as well as aid insectioning the lens 8. Alternatively, any number of other modalities maybe used such as radio frequency ablation, electric cautery, ultrasonicvibratory energy, or the like.

Ultraviolet (UV) energy can kill cells that can contribute to secondaryopacification of the capsule after primary cataract surgery. Treatingthe capsule with UV energy while the lens is being separated andsectioned from the lens capsule can reduce the rate of incidentsecondary opacification. UV energy can be applied via one or moresectioning elements 16 of the device. In some implementations, thesectioning element 16 can be a non-metal filament that can be used totransmit UV light through the sectioning element 16. For example, thesectioning element 16 can be formed of a transparent, flexible polymeror other material that can transmit the UV light therethrough. Thus, thesectioning element 16 can act as a sort of light pipe to transmit the UVenergy during capture and sectioning of the lens 8. In otherimplementations, the sectioning elements 16 can be formed of metal suchas Nitinol wire and be sheathed in a transparent polymer material thatcan be used as a light pipe to allow the UV energy to be transmittedthrough the sheathe to treat the capsule.

In some embodiments, the handle 42 may incorporate fluid deliveryfeatures. For example, as described above, the sectioning element 16 orthe shaft 12 may allow the injection of fluids through the respectivecomponents. The handle 42 may include fluid passageways and paths thatconnect these components to external fluid sources through tubes,integrated connectors, or the like. Alternatively, the handle 42 mayinclude internal pressure injection systems that push fluid through theshaft 12. The fluid may be stored in a cylinder with a piston whereinthe piston is pressed forward by actuation components in the handle 42.For example, a separate slider or button may be connected to the pistonand arranged such that as the slider is moved by the user, the piston istranslated and expels a fluid from the cylinder into the injectionsystem. This may allow the user to control the delivery of fluid throughthe sectioning element 16, the shaft 12, or any other handle 42component at certain times during the procedure such as creating spacebetween the capsular bag 6 and the lens 8. Alternatively, the surgicaldevice 40 may be configured such that the fluid is injectedautomatically by the surgical device 40 during certain periods withinthe normal actuation of the device. For example, a spring may beconfigured to place a force on the piston such that as the helical cam50 moves through its path, the piston is configured to expel an amountof fluid.

Referring to FIG. 23, an alternate embodiment of sectioning elements 16is shown as a side view. Two sectioning elements 16 extend from thedistal end of the shaft 12. In this embodiment, the sectioning elements16 are arranged to loop around the lens 8 starting at the distal end 8 aof the lens 8, rather than around the sides of the lens 8 as describedabove. The sectioning elements 16 may be extended one at a time from thedistal end of the shaft 12 distally toward the distal end 8 a of thelens 8 and into the capsular bag. The sectioning element 16 mayapproximate a loop of wire that is configured to have a predefined shapeand curves to allow it go around the lens 8 without placing excessiveforce on the capsular bag. This may include side-to-side bends as wellsas forward-and-back curves that form various three-dimensionalgeometries as the sectioning element 16 is extended from the deliverydevice. In order to enter the capsular bag and capture the lens 8, thesectioning elements 16 are configured to be shaped differently as theyexpand. Rather than being planar, these sectioning elements 16 arecurved downward from the shaft 12 in the second configuration, as seenin FIG. 23. Where multiple sectioning elements 16 are used, each may beconfigured to curve to a different degree than the other or others. Oneend of the sectioning element 16 may be extended while the other remainsrelatively fixed to the delivery device, or both ends may be extended atthe same time, as described above. As described above, the sectioningelement may have various profiles, materials, or flexibilities along itslength.

One of the sectioning elements 16 may be extended to traverse the spacebetween the capsular bag and the lens 8, and then may be moved downwardand proximally around the lens 8. A second sectioning element 16 may beextended as shown, and any number of other sectioning elements 16 may beused. In some embodiments, a forward extending sectioning element 16 maybe used in conjunction with a side extending sectioning element 16 asdescribed above, in order to create intersecting fragmentation planessuch that two sectioning elements 16 can slice the lens into 4 discretepieces. Furthermore, the fragmentation planes can be at any number ofangles to each other, and the sectioning elements 16 can extend aroundthe lens 8 from any number of directions such as a combination of theforward extending and side extending embodiments.

FIGS. 24A-24E, FIGS. 25A-25C, FIGS. 26A-26N, FIGS. 27A-27C, FIGS.28A-28B, FIGS. 29A-29B, FIGS. 30A-30E, FIGS. 31A-31F illustrateinterrelated implementations of a device 2440 for fragmentation of alens 8 within the capsular bag 6 and for removal of the lenticulartissue from the eye 1. The same or similar reference numbers may referto the same or similar structures. Aspects described with respect to thesame or similar structures may be equally applicable to the structuresdescribed elsewhere herein. Features, aspects, and methods of using eachof the devices and methods described herein may be equally applicable tothe implementations of devices and methods described below.

As with other implementations described elsewhere herein and as shown inFIGS. 24A-24E, the device 2440 can include a housing 2442 having a nosecone 2443. A distal shaft 2412 can extend from the housing 2442 along alongitudinal axis of the device, the shaft 2412 having a lumen and adistal end. The device can include a cutting element 2416 movablethrough the lumen of the shaft 2412. The cutting element and the shaft2412 are configured to be inserted through an incision 4 in the cornea2. For example, the distal shaft 2412 can have an outer diameter sizedto extend through a self-sealing incision in a cornea 2. The shaft 2412can have an outer diameter configured to insert within the anteriorchamber that is between about 0.5 mm and about 2.5 mm. In someimplementations, the shaft 2412 may have a uniform outer diameter alongits length from the nose cone 2443 to the distal tip of the shaft 2412.The outer diameter of the shaft 2412 may also have a non-uniform outerdiameter along its length. For example, in some implementations, theshaft 2412 may taper towards the distal outlet 2405 such that the outerdiameter near the distal tip is smaller than an outer diameter near thenose cone 2443. In still further implementations, the shaft 2412 mayhave a beveled edge near the distal outlet 2405. A bellows 2445 (seeFIG. 24E) can be coupled to a forward-facing, distal end of the housing2442. The bellows 2445 can be cylindrical in shape and surround aproximal end of the distal shaft 2412 extending through nose cone 2443.The bellows 2445 can be a relatively soft element. A distal end of thebellows 2445 is configured to engage and seal with an outer surface ofthe eye surrounding the incision 4 upon insertion of the shaft 2412through the incision 4. The bellows 2445 can provide a visual indicationof depth of penetration. The shaft 2412 has reached a proper depth ofpenetration once the distal end of the bellows 2445 contacts an outersurface of the eye. The bellows 2445 can thereby additionally preventover-insertion of the shaft 2412 in the eye beyond a certain desirabledepth. In some implementations, a plurality of grooves 2447 can beformed in an outer surface of the bellows 2445 giving it a ringedappearance. The grooves 2447 allow for the bellows 2445 to compressalong a longitudinal axis upon application of a force and to expandalong the longitudinal axis to be longer upon release of the force.

The cutting element of the device 2440 includes one or more sectioningelements 2416 moveably extendable through a lumen of the distal shaft2412. Each sectioning element 2416 can include a first end, a secondend, and a distal loop formed between the first and second ends, as willbe described in more detail below. At least a portion of each of thesectioning elements 2416 can be housed within corresponding one or moresecondary tubular elements or sheathes or sleeves 2415 (see FIG. 24E or26A) that are, in turn, housed within the lumen of the distal shaft2412. The cutting element is configured to transition from a first,retracted configuration towards a second, expanded configuration uponactivation of an actuator on the device 2440. When in the second,expanded configuration, the distal loop of each of the sectioningelements defines an enlarged open area. The enlarged open areas may belocated outside the distal end of the shaft 2412 and have a first legadvanced distally relative to the distal end of the shaft and a secondleg positioned proximally to the distal end of the shaft. The distalloops defining the enlarged open areas of each of the sectioningelements 2416 can be aligned generally parallel to one another within aplane (such as a vertical plane) when the cutting element is in thesecond, expanded configuration. A second activation of the actuator or asecond, different actuator may cause the distal loops defining theenlarged open areas of at least one or more of the sectioning elementsto move angularly relative to the plane thereby transitioning thecutting element into a third, splayed configuration. The secondactivation of the actuator or a second, different actuator may cause thedistal loops of the enlarged open areas of each sectioning element tomove angularly away from one another, for example, two sectioningelements moving angularly away from each other, thereby transitioningthe cutting element into the third, splayed configuration.

The sectioning elements 2416 are configured to be deployed within theeye such that loops or open areas are enlarged at a distal end of thesectioning elements 2416 that are sized to surround at least a portionof a lens 8 positioned within a capsular bag 6. The open areas definedby the distal loops of the sectioning elements 2416 are configured toexpand from the first, retracted configuration for insertion (FIG. 24A)to the second, expanded configuration (FIG. 24B) and to the third,splayed configuration (FIG. 24C). When moved from the collapsed position(FIG. 24A) toward the unbiased shape of the expanded position (FIG.24B), each of the one or more sectioning elements 2416 can form a distalloop having an unbiased (unconstrained) shape that bounds an open area2446 defined in an orientation that maximizes the open area 2446. Itshould be appreciated that use of the term “loop” when referring to thecutting end of the unbiased, unconstrained shape of the sectioningelements 2416 does not limit the open area 2446 to having a particularshape, such as a circle. The shape of the loop can be oval, elliptical,or another irregular, non-geometrical shape. The loop also need not befully closed.

The devices are described as useful for cutting a whole lens within thecapsular bag, but may be used for other purposes without departing fromvarious aspects of the device and methods described. The sectioningelements described herein may be positioned and extended between thecapsular bag and the anterior side of the lens due to natural expansionof the loops toward the expanded shape. When cutting the lens, the loopsmay extend around the posterior and anterior surfaces to form a full cutof the lens. The loops may also be moved between the posterior surfaceof the lens and the capsular bag to dissect the lens from the capsularbag before cutting the lens into fragments. The devices described hereinare particularly useful in advancing atraumatically between the bag andlens while the lens is still whole.

In an implementation, the sectioning element 2416 can include threesectioning elements 2416 a, 2416 b, 2416 c in which an intermediate loopor sectioning element 2416 b is positioned generally between the firstand second sectioning elements 2416 a, 2416 c (see FIG. 24D). Theintermediate sectioning element can likewise include a first end, asecond, end, and a distal loop formed between the first and second ends.When the cutting element is transitioned towards the second, expandedconfiguration, the distal loop of the intermediate sectioning elementmay define an enlarged open area located outside the distal end of theshaft 2412. The enlarged open area may have a first leg advanceddistally relative to the distal end of the shaft and a second legpositioned proximally to the distal end of the shaft. In thisimplementation, the sectioning elements 2416 a, 2416 b, 2416 c areconfigured to expand from the first, retracted configuration (FIG. 24A)to the second, expanded configuration (FIG. 24B) and to the third,splayed configuration (FIG. 24C). The enlarged open areas of each of thefirst, second, and intermediate sectioning elements may be alignedgenerally parallel to one another within a plane when in the second,expanded configuration. In the third, splayed configuration the outertwo sectioning elements 2416 a, 2416 c can be moved angularly away fromthe intermediate sectioning element 2416 b. A second activation of anactuator or a second, different actuator may cause the enlarged openareas of both the first and second sectioning elements to move angularlyaway from the intermediate sectioning element transitioning the cuttingelement into a third, splayed configuration. The sectioning elements2416 a, 2416 b, 2416 c can be actuated to move from the collapsedposition toward the unbiased shape of the expanded position, for examplevia a slider 2444 or other actuation mechanism positioned on the housing2442. The sectioning elements 2416 a, 2416 b, 2416 c can also beactuated to move toward the third, splayed configuration via the slider2444 and/or another actuation mechanism positioned on the housing 2442.As will be described in more detail below, the device 2440 can include atwo-phase deployment in which expansion of the loops to the second,expanded configuration can be performed independently of the splay inthe third, splayed configuration.

As described elsewhere herein, the sectioning elements 2416 can beformed of a superelastic metal and/or polymer material. The housing 2442of the device 2440 can be formed of a relatively rigid, lightweightmaterial(s). The shaft 2412 coupled to a distal end region of thehousing 2442 can have a lumen extending through it to a distal outlet2405. The shaft 2412 can be oval in cross-section with a rounded tip.The oval cross-section enhances the ability of the shaft 2412 to beinserted into the eye 1 through the corneal incision 4. The ovalcross-section also allows for a side-by-side arrangement of theplurality of sectioning elements 2416 a, 2416 b, 2416 c within thelumen. Alternately, the shaft 2412 may have a circular cross-section ora cross-section of any other suitable shape.

The distal end of the sectioning elements 2416 can extend out of theoutlet 2405 from the lumen when in the first, retracted configuration(see FIG. 24A). In such embodiments, the tight radius bend 2424 may bepositioned outside the shaft 2412, already bent at least partiallytoward the proximal direction (see FIG. 24B). In this way, even inimplementations where the sectioning element 2416 is fabricated fromsuperelastic material, the angle through which a portion of thesectioning element 2416 is bent during transition from the first,retracted configuration to the second, expanded configuration isreduced. Further, less space may be required within the lumen of theshaft 2412 to hold part of the sectioning element 2416 than to hold allof it, allowing the shaft 2412 to be made smaller in diameter.Alternately, the entirety of the sectioning elements 2416 can bepositioned within the lumen of the shaft 2412 when in the first,retracted configuration. The distal end of the sectioning element 2416,whether inside or outside the lumen in the first, retractedconfiguration, is sized and shaped to pass through a clear cornealincision 4 without damaging the eye 1. Generally, clear cornealincisions 4 are less than about 3.5 mm, although this size can vary. Themaximum outer diameter of the distal end region of the shaft 2412including the sectioning elements 2416 in the first, retractedconfiguration can be less than about 3.5 mm such that they may beinserted through a clear corneal incision, for example, between about1.5 mm and 3.5 mm.

As described elsewhere herein and as shown in FIG. 26A, each of thesectioning elements 2416 can include a first end 2418 and a second end2420, at least one of which is moveable relative to the shaft 2412. Forexample, one end (e.g. the first end 2418) of the sectioning elements2416 may be fixed relative to the shaft 2412 and another end (e.g. thesecond end 2420) of the sectioning elements 2416 may be movable relativeto the shaft 2412. When the movable end is pushed distally (i.e. axiallyalong the longitudinal axis of the device), the sectioning elements 2416translate from the first, retracted configuration toward the second,expanded configuration. When the movable end is withdrawn proximally, ifallowed, the sectioning elements 2416 translate from the second,expanded configuration toward the first, retracted configuration. Itshould be appreciated that both ends 2418, 2420 can be movable relativeto the shaft 2412 as described elsewhere herein and as will be describedin more detail below. Use of the terms “first,” “second,” or “third” arenot intended to be limiting and may be interchangeable herein, exceptwhere explicitly described as otherwise.

The sectioning elements 2416 upon extension out of the lumen of theshaft 2412 can have a distal end region or a distal loop thatapproximates or defines an open area generally in the shape of anirregular loop having a cross-section of a native lens 8. This allowsthe enlarged open area 2446 of the sectioning elements 2416 to surroundthe lens 8 within the capsular bag 6. As the end or ends 2418, 2420 arepushed distally out from the lumen, the sectioning elements 2416transition to the second, expanded configuration. As the sectioningelements 2416 transition out of the shaft 2412, the tight radius bend2424 allows the proximal section of the sectioning elements 2416 toextend proximally from the distal end of the shaft 2412, at a locationspaced from and to one side of the longitudinal centerline of the lumen2412 (i.e. longitudinal axis A of the device 2440) in the directiontoward the capsular bag 6. In this way, the sectioning elements 2416 areable to extend downward through the capsulorhexis 10 and expand to alength within the capsular bag 6 that is greater than the diameter ofthe capsulorhexis 10. For example, the sectioning elements 2416 can bemovable relative to the shaft 2412 from the first, retractedconfiguration toward a second, expanded configuration in which thelarger portion of each sectioning element 2416 extends out of the distalend of the lumen 2450. At least a portion of the sectioning elements2416 are positioned within the lumen when in the first, retractedconfiguration. It should be appreciated that some of the sectioningelements 2416 can extend outside the lumen, but that the sectioningelements 2416 and the shaft 2412 are still sized for insertion into ananterior chamber of an eye through a small corneal incision (e.g. aclear corneal incision). Motion from the first, retracted configurationtoward the second, expanded configuration can cause at least one of theends 2418, 2420 to advance distally relative to the distal end of theshaft 2412 to form the open area 2446, the open areas 2446 bounded bytheir respective sectioning elements 2416 and the distal end 2405 of theshaft 2412. At least a portion of the sectioning elements 2416 boundingthe open area 2446 extends proximally relative to the distal end 2405 ofthe shaft 2412. The second, expanded configuration of the sectioningelements 2416 is sized and shaped to permit advancement of thesectioning elements 2416 between the capsular bag 6 and the lens 8 ofthe eye while the lens remains in the capsular bag 6 to capture aportion of the lens 8 within the open area 2446. As the sectioningelements 2416 continue to expand, the plane formed by the sectioningelements 2416 can be rotated so that the sectioning elements traverse aspace between the capsular bag 6 and the lens 8. The shape plane can berotated to be primarily vertical or to any number of other anglesrelative to vertical. The rotation may be accomplished by manualrotation of the shaft 2412 of surgical device 2440 by the user. Therotation may be accomplished by integrated mechanisms within thesurgical device 2440, as described elsewhere herein.

As mentioned above, the device 2440 includes an actuator to tension thesectioning elements 2416 to reduce the size of the open areas 2446 andcut the lens 8. The actuator can be a slider 2444 movable relative tothe housing 2442 such as along the longitudinal axis of the housing. Theslider 2444 can be slideable along the top surface of the housing 2442.It should be appreciated that use of the term “slider” is not intendedto be limiting and other configurations of actuator are considered here.For example, the actuation mechanism can be a button, switch, knob, orother interface element. As best shown in FIG. 26A-26C, the slider 2444can be operatively coupled to a sled 2472 located within an interior ofthe housing 2442 via one or more fingers 2448 that extend upwardsthrough a slot 2474 in the top surface of the housing 2442. Thefinger(s) 2448 can couple to an undersurface of the slider 2444. Theslider 2444 and sled 2472 are movable within the interior of the housing2442 along the longitudinal axis A of the housing 2442. As shown in FIG.26A, a plurality of loop carriers 2476 can be coupled to the sled 2472having an arm 2482 and a proximal post 2478. The arm 2482 can extendoutward from the proximal post 2478. The proximal post 2478 can begenerally cylindrical and configured to be received through acorresponding bore 2480 of the sled 2472 (see FIG. 26B) and configuredto rotate around its respective axis of rotation within the bore 2480.

As mentioned, the proximal post 2478 is configured to rotate around itsrespective axis of rotation within its respective bore 2480. The sled2472 can be coupled to first and second loop carriers 2476 a, 2476 cpositioned on either side of the longitudinal axis A of the device 2440(see FIG. 26C-26E). The rotation of the loop carriers 2476 a, 2476 caround their respective axes of rotation R₁, R₂ and thus, the rotationalmovement of the arms 2482 a, 2482 c can be mirror image. FIG. 26Dillustrates the loop carriers 2476 a, 2476 c prior to splay. The arms2482 a, 2482 c of the loop carriers 2476 a, 2476 c are positioned in asubstantially vertical position such that they are arrangedsubstantially parallel to one another. During splay, the loop carrier2476 a positioned on a first side of the longitudinal axis A rotates afirst direction around its axis of rotation R₁ (e.g. clockwise) and theloop carrier 2476 c positioned on the opposite side of the longitudinalaxis A rotates a second direction around its axis of rotation R₂ (e.g.counter-clockwise). The arms 2482 a, 2482 c splay outward away from thesubstantially vertical starting position (e.g. orthogonal to thelongitudinal axis A) to a substantially non-vertical position. Theamount of rotation achieved by each of the arms 2482 a, 2482 c can vary,but is generally between about 15 degrees to about 45 degrees relativeto the vertical starting position.

The rotation of the loop carriers 2476 causes a corresponding rotationin the distal loops defining the enlarged open areas 2446 of thesectioning elements 2416 and thereby transitions the cutting elementinto the splayed configuration. The splayed configuration of the cuttingelement can vary. As described throughout, the distal loops defining theenlarged open areas may move angularly away from one anothertransitioning the cutting element into the splayed configuration, theangular movement being relative to a plane of the longitudinal axis ofthe device (or the longitudinal axis of the shaft or the longitudinalaxis of the lumen through which the cutting element extends). When thecutting element is in an expanded configuration such that the open areasdefined by the distal loops are expanded or otherwise enlarged away fromtheir initial insertion configuration (typically referred to herein as aretracted configuration), the distal loops defining the open areas canbe arranged generally parallel to one another within a plane, such as avertical plane, relative to the longitudinal axis of the shaft. Itshould be appreciated that when the distal loops and their enlargedopening areas are generally aligned with the plane parallel with eachother one or more portions of that distal loop may extend outside theplane. Meaning, that the enlarged open areas defined by the distal loopsmay take on a shape that is not flat (see, e.g., sectioning element 16shown in FIG. 2), but the enlarged open areas of the sectioning elementsmay be arranged substantially parallel to one another and substantiallywithin a plane relative to the device when in the second, expandedconfiguration. It should also be appreciated that the enlarged openareas need not be fully enlarged in order to be splayed relative to oneanother. Thus, where the second, expanded configuration is referred toherein it need not require the distal loops be expanded to theirmaximally expanded configuration. The second, expanded configuration caninclude an enlarged configuration in which the enlarged open areasdefined by the distal loops are expanded to less than a maximalexpansion before they are splayed relative to one another. FIG. 24Bshows sectioning elements 2416 having enlarged open areas 2446 that haveexpanded in generally two directions (i.e. along an X and Y axis) andare not yet splayed such that they are still generally compressedagainst each other (i.e. along the Z axis). FIG. 24C shows thesectioning elements 2416 in the splayed configuration where the one ormore of the distal loops defining the enlarged open areas have movedangularly away from one another (e.g. along the Z axis). In someimplementations, the cutting element has two sectioning elements and thedistal loops defining the enlarged open areas of the two sectioningelements splay apart a distance in the Z axis. One region of theenlarged open area of each distal loop (i.e. a region aligned with thelongitudinal axis of the lumen of the shaft 2412) can remain generallycompressed against a neighboring distal loop while another region of theenlarged open area (i.e. a region below the longitudinal axis of thelumen of the shaft 2412) can splay apart from the neighboring distalloop. This region of the loop that rotated and is thus splayed apart canbe positioned at an angle relative to a plane of the longitudinal axisof the shaft. The angle can vary, for example, between about 15 degreesrelative to the plane up to about 45 degrees relative to the plane.

One or more of the sectioning elements 2416 can have a fixed, first end2418 and a movable, second end 2420. For example, the movable, secondends 2420 of sectioning elements 2416 a, 2416 c are capable of movementalong the longitudinal axis A of the device 2440 such that they may bedeployed into the second, expanded configuration (see FIGS. 26B-26C).The movable, second ends 2420 a, 2420 c of the outer two sectioningelements 2416 a, 2416 c are additionally capable of angular movementwith respect to the longitudinal axis A. The second end 2420 b of theintermediate sectioning element 2416 b (shown in FIG. 24D) may be fixedsuch that it does not rotate or move angularly relative to thelongitudinal axis A. For example, the fixed, first end 2418 a of a firstsectioning element 2416 a may be fixed such that it remains stationaryduring actuation and the movable, second end 2420 a of the firstsectioning element 2416 a may be configured to be moved relative to thelongitudinal axis A of the device 2440 along at least two planes.Similarly, the fixed, first end 2418 c of a second sectioning element2416 c may be fixed such that it remains stationary during actuation andthe movable, second end 2420 c of the second sectioning element 2416 cmay be configured to be moved relative to the longitudinal axis A of thedevice 2440 along at least two planes. The fixed, first end 2418 b ofthe intermediate sectioning element 2416 b may be fixed such that itremains stationary during actuation and the moveable, second end 2420 bof the intermediate sectioning element 2416 b may be configured to bemoved relative to the longitudinal axis A of the device 2440. However,the intermediate sectioning element 2416 b may be configured to movealong a single plane and may not be capable of rotational or angularmovement relative to the longitudinal axis A. As such, all threesectioning elements 2416 a, 2416 b, 2416 c can be configured to expandupon actuation of the slider 2444, for example, by movement of theirrespective movable, second ends 2420 a, 2420 b, 2420 c along thelongitudinal axis A of the device 2440. The outer two sectioningelements 2416 a, 2416 c may have movable, second ends 2420 a, 2420 cadditionally capable of angular rotation relative to the longitudinalaxis A. The movable, second end 2420 b of the intermediate sectioningelement 2416 b can be fixed such that it does not move. It should beappreciated that the relative splaying movements of the plurality ofsectioning elements 2416 can vary and this is an example of how splaymay occur. Each of the plurality of sectioning elements 2416 can have anend capable of translation along the longitudinal axis A of the deviceas well as rotational and/or angular movements relative to thelongitudinal axis A.

With respect to FIGS. 26B-26E, the rotational movement of the loopcarriers 2476 around their respective axes of rotation R₁, R₂ providesthe rotational angular displacement that causes the outer sectioningelements 2416 a, 2416 c to splay apart from the intermediate sectioningelement 2416 b. One or more of the sectioning elements may not be shownin the figures for clarity. In an implementation, the fixed, first ends2418 a, 2418 b, 2418 c of each of the three sectioning elements 2416 a,2416 b, 2416 c can be coupled to a region of the housing 2442 or othernon-moving component of the device 2440. The movable, second ends 2420a, 2420 c of the outer two sectioning elements 2416 a, 2416 c can becoupled to distal-facing surfaces of their respective loop carriers2476. For example, a first of the loop carriers 2476 a can couple to themovable, second end 2420 a of the first sectioning element 2416 a andthe second of the loop carrier 2476 c can couple to the movable, secondend 2420 c of the second sectioning element 2416 c (see FIG. 26C). Asthe loop carriers 2476 a, 2476 c rotate around their rotational axes R₁,R₂, the ends 2420 a, 2420 c translate along with them around therotational axes R₁, R₂ towards the third, splayed configuration. FIG.26C illustrates the third, splayed configuration in which the first loopcarrier 2476 a has rotated clockwise (arrow C) such that the arm 2482 asplays to the left away from vertical and the second loop carrier 2476 chas rotated counter-clockwise (arrow CC) such that the arm 2482 c splaysto the right away from vertical. The movable ends 2420 a, 2420 c of thesectioning elements 2416 a, 2416 c travel along with the loop carriers2476 a, 2476 c towards the longitudinal axis A of the device 2440causing the loops to splay outward away from the longitudinal axis A.The movable, second end 2420 b of the intermediate sectioning element2416 b (not shown in FIG. 26C) can be coupled to the sled 2472 such thatmovements of the loop carriers 2476 do not impact its position relativeto the longitudinal axis A.

In some implementations, the device 2440 can further include a smalldiameter, thin-walled sleeve 2415 that is configured to move relative tothe longitudinal axis of the device (see FIG. 24E). At least a portionof the plurality of sectioning elements 2416 can extend through thesleeve 2415. When the sleeve 2415 is advanced distally over a greaterlength of the sectioning elements 2416, the sleeve 2415 prevents thesectioning elements 2416 from splaying away from one another and/or awayfrom the longitudinal axis A of the device 2440 even when their loopsare expanded. When the sleeve 2415 is retracted towards a proximal endof the device 2440, the sectioning elements 2416 are free to splay. Theretraction of the sleeve 2415 can be performed manually by a user.Alternatively, the retraction of the sleeve 2415 can occur automaticallyduring the phases of deployment of the sectioning elements 2416. Thesectioning elements 2416 are configured to expand from the first,retracted configuration to a second, expanded configuration. The sleeve2415 can be positioned around a length of the sectioning elements 2416in a manner that allows for their respective loops to achieve theenlarged state, but prevents splaying or angular movement of thesectioning elements 2416 relative to the longitudinal axis. Actuation ofthe sectioning elements 2416 from the second, expanded configurationtowards the third, splayed configuration can also retract the sleeve2415. Retraction of the sleeve 2415 can occur in a step-wise manner(retract, then splay) such that splay of the sectioning elements 2416relative to the longitudinal axis is possible. Each sectioning element2416 may be rigidly coupled to its respective sleeve 2415. Where thedevice includes a single sectioning element 2416, a single sleeve 2415may be incorporated. Where the device includes two sectioning elements2416, two sleeves 2415 may be incorporated, one for each sectioningelement 2416 and so on. Each sleeve 2415 allows for longitudinal,lateral, and rotational motion of its sectioning element 2416.Longitudinal motion allows for extension and expansion of the distalloops beyond the distal opening 2405 of the shaft 2412. Lateral androtational motion allows for splay or fanning of the distal loops. Thesleeves 2415 for each sectioning element 2416 aid in preventing “windup” of the wires when the sectioning elements 2416 are manipulated andprovide sufficient torsional stiffness for extension and splay.

The arms 2482 of the loop carriers 2476 can be urged into the splayedconfiguration by a wedge 2490 positioned on a wedge sled 2492. The wedge2490 can be positioned in a distal end region of the housing and have aramped surface 2494 facing towards a proximal end of the device 2440.Movement of the arms 2482 against the wedge 2490 causes the arms 2482 tobe urged away from one another and splay outward (see FIGS. 26D-26F). Asdiscussed above, the loop carriers 2476 can be coupled to the sled 2472that can slide along the longitudinal axis A of the device 2440 with theslider 2444. Distal movement of the sled 2472 can force the arms 2482 ofthe loop carriers 2476 to abut against the wedge 2490 and slide alongthe ramped surface 2494. The arms 2482 can rotate around theirrespective rotational axes such that they splay away from one another asthey slide along the ramped surface 2494 in a distal direction towardsthe thicker portion of the wedge 2490. In some implementations, thewedge 2490 is movable in a proximal direction and can be moved againstthe sled 2472 to play the arms 2482 of the loop carriers 2476.

The deployment can be a step-wise deployment including an expansion stepfollowed by a splay step. The deployment can also be a step-wisedeployment including an expansion step followed by a rotation stepfollowed by a splay step. If the device includes the retractable sleeve2415 controlling splay of the sectioning elements, the step-wisedeployment can further include a sleeve retraction step prior to or incombination with the splay step. Sliding movement of the slider 2444relative to the housing 2442 moves the sled 2472 a first distance toachieve expansion of the loops from the first, retracted configurationtowards the second, expansion configuration. Sliding movement of theslider 2444 relative to the housing 2442 moves the sled 2472 a seconddistance beyond the first distance to achieve splay of the loops (i.e.the third, splayed configuration). Rotation of the expanded loops isdescribed elsewhere herein as involving a mechanical element within thedevice itself or performed can be performed by a user.

The splay mechanism can further include an element configured to provideuser feedback regarding where in the first deployment phase the slider2444 is positioned. For example, as best shown in FIGS. 26M and 26N, theuser feedback element 2493 can be a splay detent spring configured tocontact the loop carriers 2476 immediately before the arms 2482 start tosplay. The user feedback element 2493 can be coupled near the distal endregion of the housing 2442 just proximal to the ramped surface 2494facing towards the proximal end of the device 2440. The user feedbackelement 2493 can include two springs 2491 biased towards a centerline ofthe wedge sled 2492, the distal ends of the springs 2491 located justproximal to the ramped surface 2494 of the wedge 2490. As the slidersled 2472 moves axially in a distal direction relative to the wedge sled2492, the arms 2482 of the slider sled 2472 slide between the springs2491. The distal ends of the springs 2491 may be positioned closer toone another than the proximal ends of the springs 2491 such that thesprings 2491 flex away from the centerline of the wedge sled 2492 andfrom each other as the arms 2482 past between them in a distaldirection. Each spring 2491 may include a detent 2501 near an innersurface of its distal end region. The detent 2501 forms a concavitysized and shaped to receive an outer diameter of its respective arm2482. Upon reaching the location of the detent 2501, the arms 2482 snapinto its detent 2501 providing tactile and/or audible feedback thatindicates to a user that the arms 2482 are about to contact the rampedsurfaces 2494 of the wedge 2490 if the slider 2444 is extended furtherdistally. Upon further distal extension of the slider 2444, the arms2482 pass beyond the detents 2501 of the springs 2491 and abut againstthe proximally facing ramped surfaces 2494 of the wedge 2490 to begintheir rotation

In some configurations, an initial, long distally-directed movement ofthe slider 2444 achieves the second, expanded configuration and a final,short distally-directed movement of the slider 2444 beyond this achievesthe third, splayed configuration. This step-wise deployment can expandthe loops upon a first actuation (i.e. sliding the slider 2444 a firstdistance) and can splay the loops upon a second actuation (i.e. slidingthe slider 2444 a second distance beyond the first distance). In someconfigurations, the third, splayed configuration is achieved byproximally-directed movement of the wedge 2490 towards the arms 2482. Inthis configuration, the relative position of the slider sled 2472 andthus, the arms 2482 of the loop carriers 2476 can remain fixed along thelongitudinal axis A and the wedge 2490 on the wedge sled 2492 can bemoved in a proximal direction towards the arms 2482. For example, theloops or open areas 2446 can be expanded upon a first actuation (i.e.sliding the slider 2444 a first distance in the distal direction) andthe loops or open areas 2446 can be splayed upon a second actuation(i.e. withdrawing the wedge 2490 in the proximal direction). It shouldbe appreciated that the second actuation can be performed using theslider 2444 or an actuator independent of the slider 2444, as will bedescribed in more detail below. This allows for the splayedconfiguration to be achieved regardless of the overall expansion of theloops while still providing the step-wise, two phase deployment. Assuch, even when the size of expansion is limited to a size smaller thana maximum expansion, the individual loops of the sectioning elements2416 may still be splayed from one another. Thus, the distal loops ofthe sectioning elements are configured to splay angularly away from eachother transitioning the cutting element into the third, splayedconfiguration independent of the size of the enlarged open areas.

The device 2440 allows for a user to fully adjust and select at whatpoint during wire extension the loops will begin to separate angularlyfrom one another. As described elsewhere herein, the second, expandedconfiguration of the sectioning elements 2416 can be generally oval inshape with a maximum width of about 4.0 mm to about 20 mm, and a heightof about 1.0 mm to about 15 mm. In some implementations, the second,expanded configuration of the sectioning elements 2416 can be manuallyadjustable by a user such that the size of the open area 2446 that canbe achieved upon full deployment is less than a maximum size of the openarea 2446 when the sectioning element 2416 is unconstrained. The second,expanded configuration of the sectioning elements 2416 may be limited toan intentionally smaller size than the lens 8 at certain areas or alongthe entire profile. This may improve the ability of the sectioningelements 2416 to remain close to the lens 8 and reduce interaction withthe capsular bag 6. Limiting the size of the open area 2446 of thesectioning elements 2416 to one that is less than a maximum dimensionallows for the sectioning elements 2416 to also be used as tissuemanipulators to capture small fragments of lens material to remove themfrom the capsular bag. This may eliminate the need for a second removaldevice to be used.

The maximum size of open space 2446 achievable from the sectioningelements 2416 upon actuation of the slider 2444 and prior to splay canbe manually adjusted by a user. FIGS. 26G-26L illustrate an expansionadjustment mechanism including an adjustor 2470 positioned on thehousing 2442. In some implementations, the adjustor 2470 can be arotatable knob, push button, switch, slider, or other feature configuredto be actuated by a user. It should be appreciated, use of the terms“knob” or “slider” are not intended to be limiting and that any of avariety of user inputs are considered herein that can be actuated by auser to achieve extension and/or splay of the sectioning elements 2416.The size of the enlarged open areas of the sectioning elements prior tosplay may be selectable by a user, for example, by using an adjustorconfigured to change a relative distance between the wedge and the sled.A shorter relative distance between the wedge and the sled can result ina smaller open area of the sectioning elements when urged into thesecond, expanded configuration prior to splay and a longer relativedistance between the wedge and the sled can result in a larger open areaof the sectioning elements when urged into the second, expandedconfiguration prior to splay.

In an implementation, the adjustor 2470 is rotatably coupled to aproximal end of a cam 2495 such that rotation of the adjustor 2470causes the cam 2495 to rotate. The adjustor 2470 can be coupled directlyto the proximal end of the cam 2495 or to a dowel 2499 extending throughthe cam 2495 (see FIG. 26J). The proximal end of the cam 2495 caninclude a mechanism that provides a step-wise rotation providing aseries of tactile or audible clicks providing user feedback as to thedegree of rotation achieved. In some implementations, the mechanism caninclude a plurality of detents 2484 positioned near a proximal end ofthe cam 2495 arranged to interface with a spring 2486, such as a leafspring. The spring 2486 can have an end configured to flex upward awayfrom the longitudinal axis such that it slides over the proximal end ofthe rotating cam 2495 and the flex downward to insert within each detent2484. The spring 2486 can provide a detent force as a user turns thethread. The cam 2495 can have a helical cam path 2496 on an outersurface that is configured to engage with a cam post 2497 located at aproximal end of the wedge sled 2492. As the adjustor 2470 is rotated afirst direction the cam post 2497 of the wedge sled 2492 travels alongthe helical cam path 2496 around the cam 2495 thereby sliding the wedgesled 2492 along the longitudinal axis A of the device 2440. The wedge2490 at a distal end of the wedge sled 2492 is moved towards theproximal end of the device 2440. As the wedge 2490 is withdrawn in amore proximal location along the longitudinal axis A of the device, theloops or open areas 2446 of the sectioning elements 2416 will splayearlier in the expansion stroke. Meaning, the open area 2446 of therespective sectioning elements 2416 will be smaller at the time ofsplay. The opposite movement can occur as the adjustor 2470 is rotated asecond, opposite direction. The wedge 2490 can be advanced to a moredistal location along the longitudinal axis A of the device such thatthe loops of the sectioning elements 2416 will splay later in theexpansion stroke resulting in a larger open area 2446 at the time ofsplay. The slider sled 2472 can additionally include an expansion stop2498 configured to abut the wedge 2490 thereby preventing furtherrelative sliding movement between the sled 2472 and the wedge 2490 (seeFIG. 26K). Thus, the position of the wedge 2490 can ultimately limit thetotal expansion achieved because it is incapable of moving beyond theexpansion stop 2498.

As described above, one or more retractable sleeves 2415 (see FIG. 24E)can be incorporated that maintain the sectioning elements 2416 in aconstrained configuration such that they do not splay away from thelongitudinal axis of the device before a user desires splay to occur. Aretractable sleeve 2415 may be rigidly coupled to each sectioningelement 2416 as discussed elsewhere herein and aid in the longitudinaland rotational motion of the elements 2416. The retractable sleeve 2415in this way prevents the multiple wires from creating unnecessary dragon the lens during positioning. The retractable sleeve 2415 can be usedin conjunction with a separate spreading element (e.g. the wedge 2490)to provide adjustability of the degree of splay, as described in moredetail above. Alternatively, the retractable sleeve 2415 can be used inconjunction with a plurality of sectioning elements 2416 that arepre-shaped to splay upon withdrawal of the sleeve 2415 and release ofthe constraining force. In this implementation, no separate spreadingelement (e.g. the wedge 2490) is incorporated. Each of the plurality ofsectioning elements 2416 can be pre-shaped into the third, splayedconfiguration. During expansion of the loops towards the second,expanded configuration, the sleeve 2415 can be positioned in a distallyextended position in order to keep the plurality of sectioning elements2416 constrained toward the longitudinal axis A of the device. Thesleeve 2415 can then be retracted to allow the plurality of sectioningelements 2416 to automatically splay towards their unbiased splayedconfiguration.

As described elsewhere herein, the sectioning elements 2416 can be awire having a round or oval cross-section. For example, the device caninclude a plurality of sectioning elements 2416 formed of three discretewires (e.g. 0.006″ Nitinol wire). The sectioning elements 2416 also canbe a strap or long, narrow sheet of material. For example, the devicecan include a plurality of sectioning elements 2416 formed from a band2905 of material (see FIGS. 33A-33C). In an implementation as shown inFIG. 33A, the distal end region of the band 2905 can have the pluralityof struts 2910 formed into it, each of which are shaped to form acutting loop when unconstrained, as described elsewhere herein. Theproximal end region of the band 2905 can remain as a singular band ofmaterial. In another implementation as shown in FIGS. 33B-33C, theplurality of struts 2910 can be formed into a middle region of the band2905 such that both the proximal end region and the distal end regionare flat, contiguous bands of material interspersed by the struts 2810extend therebetween. The band of material mitigates the discrete wirestangling during deployment movements. The band 2905 can be formed ofNitinol or other biocompatible material capable of shape memory. Theimplementation of FIGS. 33A-33C, the band 2905 has two cuts 2915creating three struts 2910. The band 2905 have a thickness of about0.006″ and can be about 0.022″ wide. The band 2905 can be laser cut toform the two cuts 2915 resulting in the three struts 2910. The two cuts2915 can be about 0.002″ leaving three struts 2910 that are each about0.006″ wide. The three struts 2910 can then be electro polished toremove corners reshaping the struts 2910 into the plurality ofsectioning elements 2416. The cutting and electro polishing cantransform the 0.006″×0.006″ struts 2910 into 0.006″ sectioning elements2416 that approximate a 0.006″ diameter Nitinol wire. It should beappreciated that the number of struts 2910 created can vary as can theirdimensions depending on the number of sectioning elements 2416ultimately desired for the device. For example, the width of the band2905 can depend on the number of sectioning elements 2416 to be formed.In some implementations, the band 2905 can be formed into two, three,four, or more struts 2910. It should also be appreciated that the widthand thickness of the band 2905 can, but need not be uniform and can varyover its length.

Again with respect to FIGS. 25A-25C and also FIGS. 26A-26D, once thesectioning elements 2416 have been extended to the second, expandedconfiguration (which as described above can be a fully expanded maximumopen space dimension or a dimension that is less than maximum), rotatedand/or splayed to the third, splayed configuration within the capsularbag 6 in which the sectioning elements 2416 surround at least a portionof the lens 8, the sectioning elements 2416 are then used to cut thelens 8 by tensioning the movable ends 2420 of the sectioning elements2416. The ends 2420 can be retracted through the lumen of the shaft 2412in the opposite manner as set forth above for expanding the sectioningelements 2416 from the second, expanded configuration back toward thefirst configuration in order to compress and cut the lens 8. As thesectioning elements 2416 are tensioned, they exert an inward force onthe lens 8 and begin cutting and/or fragmenting it due to the forceapplied to the lens 8 across the small surface are of the thin diametersectioning elements 2416. The tensioning may be provided by movement ofthe slider 2444 proximally, thereby pulling the movable ends of eachsectioning element 2416 proximally and tensioning it. Tensioning mayalso be provided at least in part by the user providing additional forceas described elsewhere herein.

With a single tensioning procedure, the lens 8 can be divided into two,three, or more fragments depending on the number of sectioning elements2416 incorporated. The process can be repeated along a differentrotational angle (i.e. 90 degrees to create a crisscross patternrelative to the first fragmentation) and expansion and tensioningperformed again to fragment the lens 8 into even smaller fragments (e.g.four, six, or more). The section plane is shown in FIG. 25C as primarilyvertical, but it should be appreciated that any number of angles andorientations may exist for the cutting path of the sectioning elements2416. The process may be repeated for as many times as necessary tocreate any number of lens fragments of any desired size. The finaldesired size of the lens fragments may depend on method of extractionfrom the eye 1. In some embodiments, phacoemulsification additionallymay be used in the capsular bag 6 to remove the lens fragments. This maybe particularly useful in difficult or hard cataracts, where full lensfragmentation increases the surface area and decreases the size offragments that are to be emulsified by phacoemulsification. In otherembodiments, the lens fragments may be extracted as described herein. Insome embodiments, the lens fragments by be extracted as described inU.S. Publication No. 2018/0318132, entitled “Devices and Methods forOcular Surgery,” published Nov. 8, 2018, which is incorporated byreference herein.

Upon proximal movement of the slider 2444, the sled can be returned tothe original position for safe removal of the sectioning elements 2416from the eye. The sectioning elements 2416 can be rotated back to theiroriginal plane of insertion, and then retracted into the shaft 2412.When the slider 2444 is fully withdrawn in a proximal direction, thesectioning elements 2416 can be placed in an over-strained position thatover time can be detrimental to the shape memory properties of thesectioning elements 2416. The device can include a spring 2458 that,when the loops of the sectioning elements 2416 are retracted back intothe lumen of the shaft 2412, causes the loops to not be retracted tosuch a small size that the shape memory of the Nitinol is affected. Forexample, a spring 2458 (see FIG. 24D) can be placed over aproximally-facing nose 2456 and extend proximally from the sled 2472such that the slider 2444 and sled 2472 are urged into a slightly moredistal position relative to the housing 2442 upon release of the slider2444 (see FIG. 26A-26B). If the user retracts the sectioning elements2416 too far using the slider 2444, the spring 2458 can urge the sled2472 a short distance in the distal direction after the slider 2444 isreleased by the user. This allows the loops of the sectioning elements2416 to extend slightly out the distal end 2405 of the shaft 2412 andmaintain a slightly enlarged open area 2446 when in a resting statecompared to the fully retracted state (see FIG. 24A). The size of thedistal end 2405 of the shaft 2412 and the slightly enlarged open areas2446 positioned outside the distal end 2405 of the shaft 2412 may besmall enough to be inserted through a clear corneal incision (i.e.maximum outer diameter being less than about 3.5 mm) such that thedistal loops of the sectioning elements 2416 need not ever be fullyretracted inside the lumen of the shaft 2412 in order to be insertedinto the anterior chamber of the eye.

Slider actuation can be restricted such that the device is preventedfrom being used more than for a single medical procedure. For example,one-way latches, levers, ratchets, pawls, racks, and other mechanicalelements can be incorporated within the housing to engage with theslider preventing extension of the cutting element via distal movementsof the slider and sled attached to the slider. The stroke countingmechanisms described herein may limit the device to being a single-usedevice or limited-use device. “Single-use” or “limited-use” as referredto herein means the devices described herein are intended to be used ina single patient and not intended to be re-sterilized and used onanother patient. The stroke counting mechanisms described herein mayprovide a low-cost method for limiting the use of the device, which canbe manufactured as a low-cost, disposable device. It should beappreciated the stroke counting mechanisms configured to track distalextensions and/or proximal extensions of the slider can be used with adevice having any number of sectioning elements, including 1, 2, 3, ormore sectioning elements.

Even with a single-use device, it is preferable to allow the slider 2444(or other extension/retraction mechanism) to be actuated more than asingle back-and-forth stroke. For example, a user may want to slide theslider 2444 back and forth a few times to get the feel for the deviceprior to using it on a patient. In some implementations, the device 2440can incorporate a stroke counting mechanism that allows for multipleactuations or distal extensions/proximal extensions of the slider (orother input configured to extend and retract the sectioning elements2416) a discrete number of times prior to preventing extension of theslider 2444, sled 2472 and/or sectioning elements 2416. The strokecounting mechanism thereby may limit the utility of the device afterclinical use in a single patient. The stroke counting mechanism cantrack distal extensions and/or proximal extensions of the slider andcause a lock-out event that prevents further distal extensions of theslider after the lock-out event occurs. It should be appreciated thatuse of the term “slider” is not intended to be limited and other typesof inputs configured to extend/retract the sectioning elements 2416 areconsidered herein.

In some implementations, the slider 2444 can be coupled to a strokecounting mechanism 2701. FIGS. 27A-27C shows a stroke counting mechanism2701 that can incorporate a counting pawl system. A ratchet or cogwheel2705 positioned within the handle 2442 can have a plurality of teeth2710 in operable engagement with a main sprag 2715 and a secondary sprag2720. The main sprag 2715 can be coupled to an inner region of thehousing 2442 and the secondary sprag 2720 can be coupled to the slider2444. During forward movement of the slider 2444 (i.e. towards a distalend of the housing 2442 along the direction of arrow A), a tooth 2710 ofthe cogwheel 2705 is urged against the main sprag 2715 causing thecogwheel 2705 to rotate forward one tooth 2710 around arrow B. On thebackstroke as the slider 2444 is moved towards a proximal end of thehousing 2442, the secondary sprag 2720 prevents the cogwheel 2705 fromback-driving in the opposite direction as the teeth 2710 slide back overthe main sprag 2715. The cogwheel 2705 also includes a stop tooth 2725configured to lock against a stop 2730. After the cogwheel 2705 has beenadvanced through a number of strokes, which can be defined by the numberof teeth 2710 on the cogwheel 2705, the stop tooth 2725 locks againstthe stop 2730 preventing further turning of the cogwheel 2705 in eitherdirection (see FIG. 27C). This prevents the slider 2444 from enteringthe distal end of its travel and thereby prevents the sectioningelements 2416 from being fully expanded. Movement of the sectioningelements 2416 is prevented by the lockout rendering the device 2440unusable after a certain number of extensions. The number of teeth 2710can vary, including 2, 3, 4, 5, 6, 7, 8, 9, 10, or more teeth. Afterlockout, the slider 2444 is still able to move freely in the proximalportion of its travel, allowing further constriction of the distal loopand safe removal of the sectioning elements 2416 from the eye. The mainsprag 2715 can be formed of sheet metal material having a shape thatwill bend upwards if a user attempts to over-power the main sprag 2715by urging the slider forward. Similarly, the secondary sprag 2720 can beformed of a sheet metal material. Alternatively, one or both of thesprags 2715, 2720 can be formed by a flexible piece of molded plasticthat can be deflected out of the way when the cogwheel 2705 spins in adirection B, but will not move out of the way when the cogwheel 2705spins in the opposite direction.

The stroke counting mechanisms described herein can be configured tocount the number of distal extensions, proximal extensions (i.e.retractions), or both the distal extensions and proximal extensions ofthe slider. The stroke counting mechanisms described herein can preventdistal extensions after a certain number of actuations of the sliderhave been performed. Generally, the stroke counting mechanisms describedherein do not prevent proximal movement of the slider such that thedevice is prevented from being stuck in an extended configuration withthe expanded loops trapped outside of the shaft.

The configuration of the stroke counting mechanism can vary. FIGS.28A-28B illustrate another implementation of a stroke counting mechanism2701. The stroke counting mechanism 2701 can incorporate a counting pawlsystem. A cogwheel 2705 positioned within the handle or housing 2442 canhave a plurality of teeth 2710 in operable engagement with a main sprag2715 and a secondary sprag 2720. In this implementation, the cogwheel2705 can be attached to the device housing 2442 such that it remainsstationary along the longitudinal axis of the device during movement ofthe slider 2444. The slider 2444 can have a proximally-extending arm2735 having the main sprag 2715 on its proximal end. In contrast to theimplementation of FIGS. 27A-27C in which the cogwheel 2705 is advancedduring each forward stroke of the slider 2444, the cogwheel 2705 in thisimplementation is advanced one tooth 2710 at a proximal end of eachbackstroke of the slider 2444 (arrow A of FIG. 28A). The main sprag 2715on the proximal-extending arm 2735 engages with a tooth 2710 of thecogwheel 2705 and rotates the cogwheel 2705 in a backward direction onetooth 2710 (arrow B of FIG. 28A). The cogwheel 2705 is prevented fromrotating in the opposite direction due to the presence of the secondarysprag 2720 engaging with a tooth 2710 on the cogwheel 2705. Thesecondary sprag 2720 can be positioned on an interior of the housing2442. After the cogwheel 2705 has been advanced through a discretenumber of strokes defined by the number of teeth 2710 on the cogwheel2705, a catch tooth 2740 becomes entrapped with the main sprag 2715 onthe arm 2730, which in turn cannot be advanced forward because thecogwheel 2705 is prevented from rotating in the forward direction due tothe secondary sprag 2720 (see FIG. 28B). This locks the slider 2444 inthe proximal-most position and the sectioning elements 2416 in theirmost constricted shape. The counting pawl system can have any of avariety of configurations that allow for a limited number ofretraction/extension cycles of the slider before mechanical lockingoccurs.

FIGS. 29A-29B illustrate another configuration of a stroke countingmechanism 2701. As with implementations described above, a cogwheel 2705is positioned within the handle having a plurality of teeth 2710 inoperable engagement with a main sprag 2715 and a secondary sprag 2720.The cogwheel 2705 can be attached to an interior of the device housing2442 and configured to rotate around an axis arranged perpendicular tothe longitudinal axis of the housing 2442 extending from distal end toproximal end. The cogwheel 2705 is fixed along the longitudinal axissuch that as the slider 2444 extends and retracts axially along thelongitudinal axis of the housing 2442, it engages with the teeth 2710 ofthe cogwheel 2705. The slider 2444 can have a proximally-extending arm2735 having the main sprag 2715 on its proximal end region. The mainsprag 2715 extends from the proximal end region of the arm 2735 suchthat an end of the main sprag 2715 faces towards a distal end of thehousing 2442. The teeth 2710 of the cogwheel 2705 project towards aproximal end of the housing 2442. This relative arrangement of the mainsprag 2715 and the teeth 2710 allows for the cogwheel 2705 to beadvanced during each forward stroke of the slider 2444 (i.e. towards adistal end of the housing 2442) and to remain stationary during eachbackward stroke of the slider 2444 (i.e. towards the proximal end of thehousing 2442) as the main sprag 2715 passes over the teeth 2710 of thecogwheel 2705. During forward movement of the slider 2444, a tooth 2710of the cogwheel 2705 is urged against the main sprag 2715 causing thecogwheel 2705 to rotate forward one tooth 2710 around arrow B. On thebackward stroke as the slider 2444 is moved towards the proximal end ofthe housing 2442, the secondary sprag 2720 prevents the cogwheel 2705from back-driving in the opposite direction as the teeth 2710 slide backover the main sprag 2715. The cogwheel 2705 can also include a stoptooth (like 2725 shown in FIG. 27A-27C) configured to lock against astop as described elsewhere herein.

The implementations of the counting mechanisms described above involverotation of a cogwheel around an axis that is perpendicular to thelongitudinal axis A of the housing 2442. The counting mechanism 2701 canalso include an element configured to rotate around the longitudinalaxis A of the housing 2442. FIGS. 30A-30D illustrate anotherimplementation of a stroke counting mechanism 2701 including acylindrical counting barrel 3005 positioned within the housing 2442 suchthat a central axis of the barrel 3005 is aligned coaxially with thelongitudinal axis A of the housing 2442. The counting barrel 3005 caninclude a plurality of ramp blocks 3010 projecting upward from andarranged radially around its outer surface. An underneath side of theslider 2444 can have a first slider ramp 3025 and a second slider ramp3030 (see FIG. 30D) shaped and arranged to engage with the ramp blocks3010 upon retraction and extension of the slider 2444, respectively. Theshape of each ramp block 3010 and the shape of the slider ramps 3025,3030 can vary, but are generally complementary to one another. Acomplementary shape of the ramp blocks 3010 and the slider ramps 3025,3030 allows the slider ramps 3025, 3030 to abut and slide past the rampblocks 3010. The axial movement of the ramps 3025, 3030 along thelongitudinal axis A results in rotary motion of the barrel 3005 in adirection around arrow B due to interaction with the ramp blocks 3010(see FIG. 30A). Each distal extension of the slider can turn thecylindrical counting barrel a fraction of a full revolution of thebarrel as will be described in more detail below. The barrel isconfigured to turn up to a certain number of fractions before thelock-out event occurs. The lock-out event can prevent distal extensionsof the slider while allowing proximal retraction of the slider to avoidlocking the slider when the cutting element is in the expandedconfiguration within a patient's eye.

In some implementations, the ramp blocks 3010 can have a polygonal shapewith at least two ramped surfaces relative to the longitudinal axis ofthe barrel 3005, including a front ramp 3015 configured to engage with acomplementary ramped surface on the first slider ramp 3025 and a backramp 3020 configured to engagement with a complementary ramped surfaceof the second slider ramp 3030. In some implementations, the front ramp3015 faces towards the distal end of the housing 2442 and the back ramp3020 faces towards the proximal end of the housing 2442. As such, thefirst slider ramp 3025 configured to engage with the front ramp 3015faces towards the proximal end of the housing 2442 and the second sliderramp 3025 configured to engage with the back ramp 3020 faces towards thedistal end of the housing 2442 (see FIG. 30B). On the backward stroke(i.e. towards a proximal end of the housing 2442), the first slider ramp3025 abuts the front ramp 3015 of a first ramp block 3010 a of thebarrel 3005. The barrel 3005, in turn, is rotated around thelongitudinal axis A of the device in a first direction around arrow B.The barrel 3005 rotates a fraction of a complete revolution of thebarrel 3005. After the barrel 3005 has completed its fraction of arotation and the slider 2444 continues to move backwards, the barrel3005 is prevented from rotating by an extension 3027 of the secondslider ramp 3030 (see FIG. 30E). The extension 3027 is positionedbetween two of the ramp blocks 3010 a, 3010 b on the barrel 3005 suchthat the barrel 3005 is prevented from rotating even, for example, ifthe device is shaken or dropped. The slider 2444 can prevent the barrel3005 from rotating when the slider ramps are not aligned with the rampblocks 3010 on the barrel 3005. On the forward stroke of the slider2444, the second slider ramp 3030 abuts the back ramp 3020 of the nextramp block 3010 b and rotates the barrel 3005 around the longitudinalaxis A of the housing 2442 another fraction of a complete revolution ofthe barrel 3005 around arrow B. For example, the barrel 3005 can rotate1/24 of a complete revolution on the backward stroke and another 1/24 ofa complete revolution on the forward stroke. Thus, for every forward andbackward cycle of the slider 2444, the barrel 3005 can rotate 1/12 of acomplete revolution.

The number of ramp blocks 3010 can vary depending on how many cycles ofactuation of the slider 2444 is desired (e.g. 3, 4, 5, 6, up to about19, 20, or more). The slider can extend distally about 3 to about 30strokes before the lock-out event occurs and the slider is locked in therearward position. Each barrel 3005 can additionally include a stopblock 3032 (see FIG. 30C). The stop block 3032 can be positioned on theouter surface of the barrel 3005 after than last ramp block 3010. Thestop block 3032 may include a front ramp 3015. However, the stop block3032 may have no back ramp 3020. Instead, the stop block 3032 mayinclude a groove 3034 arranged to prevent forward or distal translationof the slider 2444 (see FIG. 30C). The stop block 3032 can limit thebarrel 3005 to a certain number of turns. The stop block 3032 can bepositioned such that it engages with the slider ramps when the slider2444 is moving forward or when the slider 2444 is moving backward.

The position of the slider 2444 when it engages with the stop block 3032can be anywhere along its range of motion. For example, the slider 2444can engage with the stop block 3032 when the slider 2444 is in the mostforward position, the most backward position, or at any point betweenthe two. In some implementations, the slider 2444 engages with the stopblock 3032 about mid-way through its range of motion on a forwardstroke. There are several potential advantages to this configurationrelated to the shape of the sectioning element 2416 at the front of thedevice. For example, the sectioning element 2416 is able to betransitioned into its smallest configuration even if the stroke countingmechanism has reached its limit and a lock-out event has occurred. Thisis useful so that the device can always be removed from the eye throughthe corneal incision by retracting the slider fully.

In some implementations, the counting barrel 3005 includes a pluralityof ramp blocks 3010 within an internal passage 3035 (shown in FIGS. 31Cand 31E). The plurality of ramp blocks 3010 may be arranged radiallyaround the inner surface of the internal passage 3035. As with theimplementation described above, each ramp block 3010 can include a frontramp 3015 and a back ramp 3020 configured to be placed in operableengagement with a first slider ramp 3025 and a second slider ramp 3030upon retraction and extension of the slider 2444. In thisimplementation, a proximal end region of the slider 2444 can extendthrough the internal passage 3035 of the counting barrel 3005 such thatthe slider ramps 3025, 3030 can come into engagement with the rampblocks 3010. The outer surface of the barrel 3005 can include a helicalthread 3040 (visible in FIG. 31B) configured to engage a correspondingfemale thread on an inner surface of the housing 2442. As the barrel3005 turns, the barrel 3005 threads down a length of the housing 2442 inan axial direction. Eventually, the barrel 3005 reaches a hard-stop thatprevents the barrel 3005 from moving any further in an axial directionand the device is locked out. Thus, the barrel 3005 can go throughmultiple revolutions before a lock-out event occurs and it reaches thehard-stop. The hard-stop can include a termination of the female threadon the inner surface of the housing 2442. The helical thread 3040 canlimit the barrel 3005 to a certain number of turns, for example, 2.5turns of travel. The barrel 3005 can rotate through 2.5 turns×12strokes/turn or a total of 30 strokes before hitting the hard-stop. Atthe hard-stop, the slider 2444 can get trapped in the rearward part ofthe travel and the device is prevented from being used again.

In some implementations, the device can include mechanism to provide awarning before lock-out of actuation occurs (see FIG. 31F). The lock-outwarning feature can be mechanical, for example, a window 3042 extendingthrough the housing 2442 providing a visible sign or indication of theposition of the barrel 3005 within the housing 2442, for example,relative to the hard-stop. The window 3042 can be arranged near where auser can easily view it during use (e.g. on the top of the device nearwhere a user might be holding the device). The window 3042 allows a userto see a contrasting color as the indexing barrel 3005 translatesrearward. When the barrel 3005 is positioned near the window 3042 of thehousing 2442, the color of the barrel 3005 may be visible through thewindow 3042 providing an indication of the number of distal extensionsstill available before a lock-out event occurs. For example, the outersurface of the barrel 3005 can be viewed through the window 3042 duringuse. When the barrel 3005 is in a more distal position within thehousing 2442 and still has quite a few strokes available, the barrel3005 can be positioned distal to the window 3042 such that it is notvisible through the window 3042 and the window 3042 appears dark or afirst color. The barrel 3005 can remain distal to the window 3042 for anumber of strokes until the barrel 3005 approaches the stop (e.g. thestop block 3032 or other stop as described elsewhere herein). At thisstage when only a few more strokes are available, the outer surface ofthe barrel 3005 can be visible through the window 3042. The color of theouter surface of the barrel 3005 can be easily identifiable through thewindow 3042. The barrel 3005 may be a distinct color that is readilyidentifiable compared to a color of the handle 2442 (e.g. orange or redwhere the handle 2442 is white or gray) alerting the user to theposition of the barrel 3005 before lock-out occurs. Alternatively, theouter surface of the barrel 3005 can be visible through the window 3042prior to and during use. The outer surface of the barrel 3005 can haveat least two contrasting colors that notifies the user where the barrel3005 is in its travel. For example, a proximal end region of the barrel3005 can be viewed through the window 3042 prior to use. The outersurface of the proximal end region of the barrel 3005 can be a firstcolor (e.g. black or blue). With each translation cycle of the slider2444, the barrel 3005 is urged in a proximal direction within thehousing 2442 until a distal end region of the outer surface of thebarrel 3005 is visible through the window 3042. The outer surface of thedistal end region of the barrel 3005 can be a different color (e.g.orange or red). Thus, as the barrel 3005 approaches its stop within thehousing 2442, the different color can be visible through the window 3042alerting the user the barrel 3005 is near the end of its life.

In some implementations, the barrel 3005 has a series of markings 3007on its outer surface. For example, FIG. 30A-30E shows the barrel 3005has the numbers ‘1’ through ‘20’ marked on the outer surface. Themarkings 3007 can line up with the window 3042 in the top housing suchthat the markings 3007 on the barrel 3005 aligned with the window 3042are visible to the user. The markings 3007 may be numbers correspondingto the number of cycles remaining, the number of cycles used, etc. suchthat the user is made aware of the status of the stroke countingmechanism. Further, the slider 2444 may also have a window 3009 alongits length (see FIG. 30D). The window 3009 of the slider 2444 may lineup with the window 3042 through the top housing 2442 such that themarking(s) 3007 on the barrel 3005 at a particular position of theslider 2444 aligns with the windows 3009, 3042 and is visible to theuser. For example, when the slider 2444 is advanced fully distallyforward and the sectioning element 2416 of the device is fully open,then the window 3009 of the slider 2444 may line up with the window 3042of the top housing so that the user can see the corresponding number atthis time. As the slider 2444 is retracted proximally, the window 3009of the slider 2444 moves and the slider 2444 blocks the view of themarkings 3007 on the barrel 3005 through the top housing 2442. In thisway, the slider 2444 can act like a shutter that is only open at a givenslider position. This may be beneficial in some embodiments of thedevice to prevent users from tampering with the barrel 3005 or trying torotate it backwards to ‘reset’ the stroke counting mechanism 2701. Sucha shutter mechanism can be incorporated into any of the implementationsdescribed herein and any number of other shutter designs arecontemplated.

In still further implementations, the counting mechanism 2701 need notinvolve rotation of a barrel or cogwheel as in the implementationsdescribed above and can instead involve linear actuators. FIGS. 32A-32Billustrate an implementation of a counting mechanism 2701 that includesan axially sliding rack 3050. The rack 3050 can include a plurality ofteeth 2710 configured to engage with a corresponding element such ascamming bumps 3052 on a proximally-extending arm 2735 of the slider2444. The proximally-extending arm 2735 is configured such that it isgenerally not in contact with the rack 3050 for the majority of itsstroke. As best shown in FIG. 32A, the proximally-extending arm 2735 inan unstressed, straight position can be aligned with longitudinal axisA. As the slider 2444 is retracted proximally, the proximally-extendingarm 2735 can flex away from the longitudinal axis A in a downwarddirection away from the teeth 2710 of the rack 3050. As the slider 2444is advanced distally, the proximally-extending arm 2735 can relax backtoward the longitudinal axis A in an upward direction toward the teeth2710 of the rack 3050. The one or more camming bumps 3052 on aproximal-most end of the arm 2735 are configured to engage with one ormore camming profiles 3054 on the interior of housing 2442 as the slider2444 is moved proximally and distally. As the slider 2444 is retractedproximally, the camming bumps 3052 on the proximally-extending arm 2735engage with the camming profile 3054 on the housing 2442 causing theproximally-extending arm 2735 to be urged downward (see arrow A of FIG.32A). The proximally-extending arm 2735 elastically flexes downwardrelative to the slider 2444 and the housing 2442. Once the camming bumps3054 slide proximally past the camming profile 3054, theproximally-extending arm 2735 can return upward back to its unstressed,straight position aligned with longitudinal axis A. As the slider 2444is advanced distally, for example, to extend the sectioning element onceagain, the camming bumps 3052 engage with the camming profile 3054 onthe housing 2442. The proximally-extending arm 2735 is urged upward andflexes toward the rack 3050 away from the longitudinal axis A. A feature3056 on the slider 2444 engages with the teeth 2710 on the rack 3050causing the rack 3050 to advance forward with the slider 2444 while theproximally-extending arm 2735 is flexed upward. Once the camming bumps3052 advance distally past the camming profile 3054, theproximally-extending arm 2735 relaxes downward away from the teeth 2710and to its neutral unstressed state aligned with longitudinal axis A.With each cycle backward and forward of the slider 2444, the cammingbumps 3052 move around the camming profiles 3054 and the rack 3050 isadvanced a given distance. During proximal travel of the slider 2444,the camming bumps 3052 travel down below the camming profile 3054 andthe feature 3056 moved away from the teeth 2710 of the rack 3050. Duringdistal travel of the of the slider 2444, the camming bumps 3052 travelback up above the camming profile 3054 and the feature 3056 is urgedagainst the teeth 2710 of the rack 3050 thereby causing the rack 3050 totravel a distance forward. After a given number of cycles, the rack 3050is configured to engage with a hard-stop on the housing such that itcannot be advanced any further. In this state, the slider 2444 isprevented from moving forward.

The devices and methods may be described in relation to preferredembodiments and it is understood that numerous modifications could bemade to the preferred embodiments. For example, the tissue manipulatorsmay have additional filaments or cross-filaments without departing fromnumerous aspects described.

In various implementations, description is made with reference to thefigures. However, certain implementations may be practiced without oneor more of these specific details, or in combination with other knownmethods and configurations. In the description, numerous specificdetails are set forth, such as specific configurations, dimensions, andprocesses, in order to provide a thorough understanding of theimplementations. In other instances, well-known processes andmanufacturing techniques have not been described in particular detail inorder to not unnecessarily obscure the description. Reference throughoutthis specification to “one embodiment,” “an embodiment,” “oneimplementation, “an implementation,” or the like, means that aparticular feature, structure, configuration, or characteristicdescribed is included in at least one embodiment or implementation.Thus, the appearance of the phrase “one embodiment,” “an embodiment,”“one implementation, “an implementation,” or the like, in various placesthroughout this specification are not necessarily referring to the sameembodiment or implementation. Furthermore, the particular features,structures, configurations, or characteristics may be combined in anysuitable manner in one or more implementations.

The use of relative terms throughout the description may denote arelative position or direction. For example, “distal” may indicate afirst direction away from a reference point. Similarly, “proximal” mayindicate a location in a second direction opposite to the firstdirection. However, such terms are provided to establish relative framesof reference, and are not intended to limit the use or orientation of ananchoring delivery system to a specific configuration described in thevarious implementations.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of what is claimed or of what maybe claimed, but rather as descriptions of features specific toparticular embodiments. Certain features that are described in thisspecification in the context of separate embodiments can also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment canalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination can in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Only a few examples and implementations are disclosed.Variations, modifications and enhancements to the described examples andimplementations and other implementations may be made based on what isdisclosed.

In the descriptions above and in the claims, phrases such as “at leastone of” or “one or more of” may occur followed by a conjunctive list ofelements or features. The term “and/or” may also occur in a list of twoor more elements or features. Unless otherwise implicitly or explicitlycontradicted by the context in which it is used, such a phrase isintended to mean any of the listed elements or features individually orany of the recited elements or features in combination with any of theother recited elements or features. For example, the phrases “at leastone of A and B;” “one or more of A and B;” and “A and/or B” are eachintended to mean “A alone, B alone, or A and B together.” A similarinterpretation is also intended for lists including three or more items.For example, the phrases “at least one of A, B, and C;” “one or more ofA, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, Balone, C alone, A and B together, A and C together, B and C together, orA and B and C together.”

Use of the term “based on,” above and in the claims is intended to mean,“based at least in part on,” such that an unrecited feature or elementis also permissible.

What is claimed is:
 1. A surgical device for cutting a lens within a capsular bag of an eye, the device comprising: a housing comprising a distal nose cone; a shaft extending from the distal nose cone of the housing along a longitudinal axis of the device, the shaft having at least one lumen and a distal end; a cylindrical element positioned around a proximal end region of the shaft, the cylindrical element configured to engage and seal with an outer surface of the eye upon insertion of the shaft through a corneal incision in the eye; a cutting element movable through the lumen of the shaft, the cutting element comprising: at least a first sectioning element having a first end, a second end, and a distal loop formed between the first and second ends; and an actuator operatively coupled to the cutting element, wherein the cutting element is configured to transition from a first, retracted configuration towards a second, expanded configuration upon a first activation of the actuator, and wherein, when in the second, expanded configuration, the distal loop of the first sectioning element defines an enlarged open area located outside the distal end of the shaft, the enlarged open area having a first leg advanced distally relative to the distal end of the shaft and a second leg positioned proximally to the distal end of the shaft, and
 2. The device of claim 1, wherein the cylindrical element provides a visual indication of depth of penetration of the shaft.
 3. The device of claim 1, wherein the cylindrical element limits depth of insertion of the shaft into the eye.
 4. The device of claim 1, wherein the cylindrical element is elastomeric and comprises a plurality of grooves on an outer surface allowing for the cylindrical element to compress along the longitudinal axis of the shaft upon an application of a force and to expand along the longitudinal axis of the shaft upon release of the force.
 5. The device of claim 1, wherein the cutting element further comprises a second sectioning element, wherein the second sectioning element has a first end, a second end, and a distal loop formed between the first and second ends.
 6. The device of claim 5, further comprising a sled positioned within the housing having a first loop carrier coupled to the first sectioning element and a second loop carrier coupled to the second sectioning element.
 7. The device of claim 6, wherein the actuator is a slider movable along the longitudinal axis of the housing, wherein the sled is coupled to move with the slider relative to the housing.
 8. The device of claim 7, wherein movement of the slider a first distance in a distal direction relative to the housing translates the sled distally causing the distal loops of the first and second sectioning elements to define the enlarged open areas and transition the cutting element towards the second, expanded configuration.
 9. The device of claim 8, wherein, when the cutting element is in the second, expanded configuration, the distal loops defining the enlarged open areas of each of the first and second sectioning elements are aligned generally within a plane parallel to one another.
 10. The device of claim 9, wherein a second activation of the actuator or a second, different actuator causes the distal loop defining the enlarged open area of one of the first and second sectioning elements to move angularly relative to the plane transitioning the cutting element into a third, splayed configuration.
 11. The device of claim 10, wherein a size of the enlarged open areas of the first and second sectioning elements prior to splay is selectable using an adjustor.
 12. The device of claim 11, wherein the adjustor is configured to change a relative distance between the sled and a wedge positioned within the housing, wherein a shorter relative distance achieves a smaller open area of the first and second sectioning elements in the second, expanded configuration prior to splay, and wherein a longer relative distance achieves a larger open area of the first and second sectioning elements prior to splay.
 13. The device of claim 1, wherein the actuator is a slider and the device further comprises a stroke counting mechanism coupled to the slider and contained within the housing, wherein the stroke counting mechanism is configured to track distal extensions and/or proximal extensions of the slider.
 14. The device of claim 13, wherein the stroke counting mechanism is configured to cause a lock-out event that prevents distal extension of the slider after the lock-out event.
 15. The device of claim 14, wherein the stroke counting mechanism comprises: a cylindrical counting barrel having a plurality of ramp blocks; a hard stop; and a pair of slider ramps shaped and arranged to engage with the plurality of ramp blocks on the counting barrel causing the counting barrel to rotate around the longitudinal axis.
 16. The device of claim 15, wherein each distal extension of the slider turns the cylindrical counting barrel a fraction of a full revolution around the longitudinal axis.
 17. The device of claim 16, wherein the cylindrical counting barrel is configured to turn up to about 24 fractions before the lock-out event occurs.
 18. The device of claim 17, wherein the lock-out event prevents distal extension of the slider and allows proximal retraction of the slider.
 19. The device of claim 18, wherein the slider is configured to extend about 3 to about 30 strokes in a distal direction before the lock-out event occurs and the slider is locked in a rearward position.
 20. The device of claim 13, wherein the device is a single-use, disposable device. 